MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-05 for LINK 75-3122 manufactured by Waldemar Link Gmbh & Co..
[19835]
Surgeon tore dura when using a trial rongeur. The rongeurs in question were tested after return by an independent lab. The test did not reveal any mechanical or design defects that would lead to malfunction. Test report on file.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000810 |
| MDR Report Key | 27030 |
| Date Received | 1995-10-05 |
| Date of Report | 1994-08-16 |
| Date of Event | 1994-05-17 |
| Date Added to Maude | 1995-10-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINK |
| Generic Name | KERRISON RONGEUR |
| Product Code | HAD |
| Date Received | 1995-10-05 |
| Model Number | 75-3122 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27822 |
| Manufacturer | WALDEMAR LINK GMBH & CO. |
| Manufacturer Address | BARKHAUSENWEG 10 HAMBURG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-10-05 |