MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-06-21 for manufactured by .
[7845358]
Since this instrument is faultless as to its technical functions, we feel that no corrective or preventive actions have to be taken on our part. The tips of the instrument involved were polished/refurbished and the forceps were returned to the distributor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010456-2006-00001 |
| MDR Report Key | 728808 |
| Report Source | 08 |
| Date Received | 2006-06-21 |
| Date Mfgr Received | 2006-05-23 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-06-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GUENTER BISSINGER |
| Manufacturer Street | GOTTLIEB-DAIMLER-STRASSE 5 |
| Manufacturer City | TENINGEN 79331 |
| Manufacturer Country | GM |
| Manufacturer Postal | 79331 |
| Manufacturer Phone | 641914330 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | LYT |
| Date Received | 2006-06-21 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 699153 |
| Baseline Brand Name | CUSHING, 19CM (7.50"), 0.7M |
| Baseline Generic Name | NON-STICK BIPOLAR |
| Baseline Model No | * |
| Baseline Catalog No | N19C07 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-21 |