MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-07-26 for NUGRIP SZ. 20M NUG-443-20M manufactured by Ascension Orthopedics.
[3673213]
It was reported the consumer had cmc arthroplasty on (b)(6) 2013 for "bone on bone" arthritis of his right thumb. He has experienced tightness of his right thumb, and sensory deficit along the top part of his thumb to his wrist. He reported he underwent 30 to 35 physical therapy sessions. Additional clinical info was requested by integra.
Patient Sequence No: 1, Text Type: D, B5
[10910370]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2013-00022 |
| MDR Report Key | 3254174 |
| Report Source | 04 |
| Date Received | 2013-07-26 |
| Date of Report | 2013-07-26 |
| Date Mfgr Received | 2013-07-10 |
| Date Added to Maude | 2013-08-15 |
| 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 | CAREN FINKEISTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUGRIP SZ. 20M |
| Generic Name | NUGRIP |
| Product Code | KYI |
| Date Received | 2013-07-26 |
| Catalog Number | NUG-443-20M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-26 |