MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-03-28 for WRIST BRACE W/BOA, BLK, LT, M 221-51-1111 manufactured by Djo, Llc.
[140325062]
There is no indication from the reporter that the device will be returned for evaluation. If the device is returned, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
[140325063]
It was reported that the splint caused the patient pain and redness. The patient was placed in the splint in an orthopedic office and complained of the pain and redness, after which she was placed in a new splint. It was discovered that the foam inside of the splint had been cut too short, exposing the hard area on a portion of the splint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2019-00014 |
| MDR Report Key | 8460755 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-28 |
| Date of Event | 2018-12-26 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN BECKER |
| Manufacturer Street | 1430 DECISION ST. |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, B.C. 22244, |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WRIST BRACE W/BOA, BLK, LT, M |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2019-03-28 |
| Model Number | 221-51-1111 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION ST. VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |