International safety notice
Alert 2886 (Technovigilance) - Promedon do Brasil Produtos Médico Hospitalares Ltda - Flowable Dispersible Matrix for Wounds Specific batch presents quality deviation.
Brazil / Anvisa · BRA · May 27, 2019
Key facts
| Title | Alert 2886 (Technovigilance) - Promedon do Brasil Produtos Médico Hospitalares Ltda - Flowable Dispersible Matrix for Wounds Specific batch presents quality deviation. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Flowable Wound Dispersible Matrix Technical Name: Adhesion barrier gel ANVISA registration number: 10306840141 Risk Class: IV Affected model: FWD301 Affected batch number: 2991332 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PROMEDON DO BRASIL PRODUTOS MÉDICO HOSPITALARES LTDA CNPJ 00028682000140 AV GUIDO CALOI 1935 BL C1 SÃO PAULO SP EMAIL PRISCILAKUTNEYPROMEDONCOM FABRICANTE DO PRODUTO INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 ESTADOS UNIDOS DA AMÉRICA |
| Models | FWD301, 2991332, 10306840141 |
| Date | May 27, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 100–999 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