MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-10-13 for CARPAL TUNNEL KNIFE 1 PIECE 080003 manufactured by Integra.
[2250281]
The product distributor stated that there have been three cases of paresis since he began to work with this product. He requested the product instructions for use. Integra requested additional clinical and product identity info. No additional info has been received to date.
Patient Sequence No: 1, Text Type: D, B5
[9361482]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2011-00166 |
| MDR Report Key | 2301943 |
| Report Source | 01,08 |
| Date Received | 2011-10-13 |
| Date of Report | 2011-10-13 |
| Date of Event | 2011-09-15 |
| Date Mfgr Received | 2011-09-16 |
| Date Added to Maude | 2011-10-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARPAL TUNNEL KNIFE 1 PIECE |
| Generic Name | SAFEGUARD MINI CARPAL TUNNEL RELEASE SYSTEM |
| Product Code | EMF |
| Date Received | 2011-10-13 |
| Catalog Number | 080003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA |
| Manufacturer Address | CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-10-13 |