MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-01 for WINNER X BLACK 10 1/2 XWIDE 7710-X-10.5 manufactured by Dr. Comfort, A Djo, Llc Company.
[134768832]
Reporter: unknown.
Patient Sequence No: 1, Text Type: N, H10
[134768833]
The customer reported that the patient experienced callouses and infection on both feet, allegedly caused by wearing the shoes.
Patient Sequence No: 1, Text Type: D, B5
[134772292]
Reporter: unknown. Manufacturer narrative: the shoes were returned for evaluation. One of the shoes had been cut. There was no debris or loose stitching. The cause of the patient's callouses and infection was not determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008579854-2019-00004 |
| MDR Report Key | 8298087 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-30 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2019-02-01 |
| 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 | 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 10 1/2 XWIDE |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2019-02-01 |
| Returned To Mfg | 2019-01-24 |
| Model Number | 7710-X-10.5 |
| Lot Number | 271135 |
| 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. Required No Informationntervention | 2019-02-01 |