MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-18 for SNARE WIRES # 9 2409 manufactured by Richard Allan Medical, Inc..
[19493304]
Pt having tonsillectomy. Upon snaring rt tonsil, wire fractured. Both pieces retrieved, no harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30191 |
| MDR Report Key | 30191 |
| Date Received | 1996-01-18 |
| Date of Report | 1995-12-18 |
| Date of Event | 1995-12-13 |
| Date Facility Aware | 1995-12-18 |
| Report Date | 1995-12-19 |
| Date Added to Maude | 1996-02-20 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SNARE WIRES # 9 |
| Generic Name | WIRE FOR SNARING TONSIL |
| Product Code | KBZ |
| Date Received | 1996-01-18 |
| Returned To Mfg | 1995-12-18 |
| Catalog Number | 2409 |
| Lot Number | 04 APR00 |
| ID Number | SIZE #9 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31291 |
| Manufacturer | RICHARD ALLAN MEDICAL, INC. |
| Manufacturer Address | 8850 M-89 P O BOX 351 RICHLAND MI * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-01-18 |