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 2019-11-21 for HOLD-FORCEPS F/CERCLWIRES L170 391.800 manufactured by Oberdorf Synthes Produktions Gmbh.
Report Number | 8030965-2019-70472 |
MDR Report Key | 9354284 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-21 |
Date of Report | 2019-11-06 |
Date Mfgr Received | 2019-11-06 |
Date Added to Maude | 2019-11-21 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | KARA DITTY-BOVARD |
Manufacturer Street | 1302 WRIGHTS LANE EAST |
Manufacturer City | WEST CHESTER PA 19380 |
Manufacturer Country | US |
Manufacturer Postal | 19380 |
Manufacturer Phone | 6103142063 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | HOLD-FORCEPS F/CERCLWIRES L170 |
Generic Name | FORCEPS |
Product Code | HTD |
Date Received | 2019-11-21 |
Catalog Number | 391.800 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-21 |