MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2003-10-15 for FUNDUS FCPS DA 5MM INLINE * 9010-600-107IL manufactured by Koscher & Wurtz Gmbh.
[294043]
The distributor reported that on both instruments the hinge broke during use. There was no patient injury whatsoever.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010877-2003-00003 |
| MDR Report Key | 490046 |
| Report Source | 08 |
| Date Received | 2003-10-15 |
| Date of Report | 2003-09-08 |
| Date Mfgr Received | 2003-04-09 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2003-10-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEFAN KOSCHER |
| Manufacturer Street | EINSTEINSTR 7 |
| Manufacturer City | SPAICHINGEN 78549 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78549 |
| Manufacturer Phone | 424958300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUNDUS FCPS DA 5MM INLINE |
| Generic Name | * |
| Product Code | HCZ |
| Date Received | 2003-10-15 |
| Model Number | * |
| Catalog Number | 9010-600-107IL |
| Lot Number | 0300084 |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 478788 |
| Manufacturer | KOSCHER & WURTZ GMBH |
| Manufacturer Address | EINSTEINSTRASSE 7 SPAICHINGEN GM 78549 |
| Baseline Brand Name | FUNDUS FCPS DA 5MM INLINE |
| Baseline Generic Name | * |
| Baseline Model No | * |
| Baseline Catalog No | 9010-600-107IL |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-10-15 |