MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-20 for PROLARYN PLUS INJECTABLE IMPLANT manufactured by Merz North America, Inc..
| Report Number | 3013840437-2019-00019 |
| MDR Report Key | 9347167 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-11-20 |
| Date of Report | 2019-11-20 |
| Date Mfgr Received | 2019-10-28 |
| Date Added to Maude | 2019-11-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PRODUCT SAFETY |
| Manufacturer Street | 6501 SIX FORKS ROAD |
| Manufacturer City | RALEIGH NC 27615 |
| Manufacturer Country | US |
| Manufacturer Postal | 27615 |
| Manufacturer Phone | 9195828000 |
| Manufacturer G1 | MERZ NORTH AMERICA, INC. |
| Manufacturer Street | 4133 COURTNEY STREET SUITE 10 |
| Manufacturer City | FRANKSVILLE WI 53126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLARYN PLUS INJECTABLE IMPLANT |
| Generic Name | POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) |
| Product Code | KHJ |
| Date Received | 2019-11-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA, INC. |
| Manufacturer Address | 4133 COURTNEY STREET SUITE 10 FRANKSVILLE WI 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-11-20 |