MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-12-21 for UNIVERSAL THUMB-O-PRENE 82-82700 manufactured by Djo Llc.
[19672639]
Skin irritation at thumb point (stiffener level) after wearing the thumb o prene brace for an unk period of time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00131 |
| MDR Report Key | 2387580 |
| Report Source | 06 |
| Date Received | 2011-12-21 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-11-21 |
| Date Mfgr Received | 2011-11-21 |
| Date Added to Maude | 2011-12-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST. |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL THUMB-O-PRENE |
| Generic Name | THUMB-O-PRENE |
| Product Code | ILH |
| Date Received | 2011-12-21 |
| Returned To Mfg | 2011-12-15 |
| Model Number | 82-82700 |
| Lot Number | 062210 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO LLC |
| Manufacturer Address | 1430 DECISION ST. VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-21 |