MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-07 for WINNER X BLACK 12 XWIDE 7710-X-12.0 manufactured by Dr. Comfort, A Djo, Llc Company.
[132263298]
The device is not available for evaluation. If the device becomes available as such, a follow-up report will be submitted upon completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[132263299]
It was reported that the patient had an open sore that got infected, requiring hospitalization, while wearing the shoes. The patient received the shoes on (b)(6) 2018 and wore them the same day. After wearing the shoes for four days, the patient got an open sore that wouldn't heal and became infected. The patient was hospitalized for three days. The shoes were reportedly "half an inch bigger on the toe".
Patient Sequence No: 1, Text Type: D, B5
[134387594]
The shoes were returned for evaluation. No fault was found with these shoes. As such, the cause of the reported event was not determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008579854-2019-00001 |
| MDR Report Key | 8223323 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-07 |
| Date of Report | 2019-01-29 |
| Date of Event | 2018-12-09 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2019-01-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BECKER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DR. COMFORT, A DJO, LLC COMPANY |
| Manufacturer Street | 10300 ENTERPRISE DR. |
| Manufacturer City | MEQUON WI 53092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINNER X BLACK 12 XWIDE |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2019-01-07 |
| Returned To Mfg | 2019-01-10 |
| Model Number | 7710-X-12.0 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR. COMFORT, A DJO, LLC COMPANY |
| Manufacturer Address | 10300 ENTERPRISE DR. MEQUON WI 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-01-07 |