MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for ERBE APC 2 10134-000 manufactured by Erbe Elektromedizin Gmbh.
| Report Number | 9610614-2020-00009 |
| MDR Report Key | 9902432 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2016-10-19 |
| Date Added to Maude | 2020-03-31 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN TARTAL |
| Manufacturer Street | 2225 NORTHWEST PARKWAY |
| Manufacturer City | MARIETTA, GA |
| Manufacturer Country | US |
| Manufacturer G1 | ERBE ELEKTROMEDIZIN GMBH |
| Manufacturer Street | WALDHORNLESTRASSE |
| Manufacturer City | TUBINGEN 72072 |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERBE APC 2 |
| Generic Name | ARGON PLASMA COAGULATOR |
| Product Code | GEI |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-17 |
| Model Number | APC 2 |
| Catalog Number | 10134-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERBE ELEKTROMEDIZIN GMBH |
| Manufacturer Address | WALDHORNLESTRASSE TUBINGEN 72072 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |