MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-09-20 for CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6 121-135 / AR 200-16-61 manufactured by Geomed Medizin-technik Gmbh & Co. Kg.
| Report Number | 8010168-2019-00001 |
| MDR Report Key | 9098906 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-09-20 |
| Date of Report | 2019-09-20 |
| Date Mfgr Received | 2019-08-21 |
| Date Added to Maude | 2019-09-20 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANNO HAUG |
| Manufacturer Street | LUDWIGSTALER STRASSE 27 |
| Manufacturer City | TUTTLINGEN, BADEN WUERTTEMBERG 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | GEOMED MEDIZIN-TECHNIK GMBH & CO. KG |
| Manufacturer Street | LUDWIGSTALER STRASSE 27 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6 |
| Generic Name | NEEDLE HOLDER |
| Product Code | DWS |
| Date Received | 2019-09-20 |
| Catalog Number | 121-135 / AR 200-16-61 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEOMED MEDIZIN-TECHNIK GMBH & CO. KG |
| Manufacturer Address | LUDWIGSTALER STRASSE 27 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-20 |