MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-10-28 for 200068 manufactured by Biomet, Inc..
[17113107]
It was reported that following carpal tunnel release procedure in 2005, pt complained of numbness. Pt returned to surgery three days later to repair median nerve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2005-00083 |
| MDR Report Key | 644188 |
| Report Source | 07 |
| Date Received | 2005-10-28 |
| Date of Report | 2005-10-03 |
| Date of Event | 2005-09-22 |
| Date Mfgr Received | 2005-10-03 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2005-11-03 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY HARDESTY, SPEC. |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET, INC. |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL |
| Product Code | EKD |
| Date Received | 2005-10-28 |
| Model Number | NA |
| Catalog Number | 200068 |
| Lot Number | 603460 |
| ID Number | NA |
| Device Expiration Date | 2015-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 633622 |
| Manufacturer | BIOMET, INC. |
| 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 | 2005-10-28 |