MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-05-12 for INDIANA TOME RD450060 manufactured by Biomet, Inc..
[156670]
Carpal tunnel release procedure was performed on 02/13/97 during which injury to the median nerve was sustained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-1999-00055 |
| MDR Report Key | 223275 |
| Report Source | 00 |
| Date Received | 1999-05-12 |
| Date of Report | 1999-05-11 |
| Date of Event | 1997-02-13 |
| Date Facility Aware | 1999-04-19 |
| Report Date | 1999-05-11 |
| Date Mfgr Received | 1999-04-12 |
| Device Manufacturer Date | 1997-02-01 |
| Date Added to Maude | 1999-05-18 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DEB VOYNOVICH, SPEC. |
| Manufacturer Street | PO BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 2192676639 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDIANA TOME |
| Generic Name | INSTRUMENT, MANUAL, SURGICA |
| Product Code | EKD |
| Date Received | 1999-05-12 |
| Model Number | NA |
| Catalog Number | RD450060 |
| Lot Number | 962640 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 216533 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | PO BOX 587 WARSAW IN 465810587 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-05-12 |