MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-04 for TEE PEE 223084 manufactured by Medical Specialties.
[850873]
Tee pee thumb splint worn three days cut my wrist resulting in wrist pain, as well as thumb pain for which splint was prescribed by doctor. The plastic "stay" cut into my wrist below, the thumb (on right hand) causing pain. I stopped use after 3 days, but pain in wrist remains. Note: i have seen my doctor three times, have seen an orthopedic specialist once, visited physiotherapist for one month, received massage therapy the past four months. I wear the splint 70%-90% of each day (taken off when typing or washing dishes) on advice of therapist to begin to strengthen wrist and do therapeutic exercises. I feel the tee pee contributed to this. If there had been either a shorter plastic stay or an extended stay like in the thumb/wrist splint, my wrist would not have been injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007126 |
| MDR Report Key | 1056183 |
| Date Received | 2008-06-04 |
| Date of Report | 2008-05-14 |
| Date of Event | 2007-12-14 |
| Date Added to Maude | 2008-06-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEE PEE |
| Generic Name | THUMB SUPPORT |
| Product Code | FYH |
| Date Received | 2008-06-04 |
| Model Number | 223084 |
| ID Number | BAR CODE: 2 08357 230846 |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1026135 |
| Manufacturer | MEDICAL SPECIALTIES |
| Manufacturer Address | WADESBORO NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-04 |