MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-25 for SECURITY BLADE * 20068 manufactured by Biomet Orthopaedics.
[429748]
Right carpal tunnel release performed. Patient returned home. Patient returned 2005 with numbness in right index finger. Right median nerve had been partially cut. Nerve was repaired and patient released to home without further problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 644123 |
| MDR Report Key | 644123 |
| Date Received | 2005-10-25 |
| Date of Report | 2005-10-24 |
| Date of Event | 2005-09-22 |
| Date Facility Aware | 2005-09-25 |
| Report Date | 2005-10-24 |
| Date Reported to FDA | 2005-10-24 |
| Date Reported to Mfgr | 2005-10-24 |
| Date Added to Maude | 2005-11-03 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | SECURITY BLADE |
| Generic Name | CARPAL TUNNEL RELEASE SYSTEM |
| Product Code | EKD |
| Date Received | 2005-10-25 |
| Model Number | * |
| Catalog Number | 20068 |
| Lot Number | 603460 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 633622 |
| Manufacturer | BIOMET ORTHOPAEDICS |
| Manufacturer Address | P O BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | SECURITY BLADE |
| Baseline Generic Name | INSTRUMENT, MANUAL, SURGICAL |
| Baseline Model No | NA |
| Baseline Catalog No | 200068 |
| Baseline ID | NA |
| Baseline Device Family | SECURITY BLADE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 120 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-10-25 |