International safety notice
Alert 2949 (Technovigilance) - Medstar Importação e Exportação Eireli - Promogran Prisma Wound Balance Matrix Possibility of breaking the sterile barrier of specific batch units.
Brazil / Anvisa · BRA · Aug 16, 2019
Key facts
| Title | Alert 2949 (Technovigilance) - Medstar Importação e Exportação Eireli - Promogran Prisma Wound Balance Matrix Possibility of breaking the sterile barrier of specific batch units. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Promogran Prisma Wound Balance Matrix Technical Name: Regenerating Membranes ANVISA registration number: 80047300346 Risk Class: IV Affected model: PS2123 (Box of 10 units) Affected serial numbers: 1904V001 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO EIRELI CNPJ 03580620000135 RUA VALÊNCIO SOARES RODRIGUES 89 SALA 1 VARGEM GRANDE PAULISTA SP TEL 11 50923700 EMAIL JFMENEZESMEDSTARCOMBR FABRICANTE DO PRODUTO SYSTAGENIX WOUND MANAGEMENT LIMITED GARGRAVE NORTH YORKSHIRE BD23 3RX REINO UNIDO |
| Models | 1904V001, 80047300346, PS2123 |
| Date | Aug 16, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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