International safety notice
Alert 2623 (Technovigilance) - BMD Comércio de Produtos Médicos Ltda - Abviser Autovalve Intra-Abdominal Pressure Monitoring Device (IAP) Possibility of breaking the sterile barrier.
Brazil / Anvisa · BRA · Jul 23, 2018
Key facts
| Title | Alert 2623 (Technovigilance) - BMD Comércio de Produtos Médicos Ltda - Abviser Autovalve Intra-Abdominal Pressure Monitoring Device (IAP) Possibility of breaking the sterile barrier. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Abviser Autovalve Intra-Abdominal Pressure Monitoring Device (IAP) Technical Name: Devices ANVISA registration number: 80523020033 Risk Class: II Affected model: ABV 301 Affected serial numbers: Lots: 161128 / 170120 / 170552 / 170514 / 170711 / 170829 / 170913 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BMD COMÉRCIO DE PRODUTOS MÉDICOS LTDA AVENIDA PORTUGAL 1100 PARTE C22 ITAPEVI SP TEL 1135291870 EMAIL NATALIAMONTINICONVATECCOM FABRICANTE DO PRODUTO CONVATEC INC 211 AMERICAN AVENUE GREENSBORO CAROLINA DO NORTE 27409 ESTADOS UNIDOS |
| Models | 170514, 161128, 170711, 170829, 170552, 80523020033, 170120, 170913 |
| Date | Jul 23, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1