MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-26 for DR COMFORT 7610-W-11.5 manufactured by Dr Comfort A Djo, Llc Company.
[20019674]
Per 21 cfr part 803, an mdr reportable event. Complaint received from clinician that alleges "shoe bothered patients bunion and as a result, his toe was removed a few weeks ago. " questionnaire was not received from clinician and/or patient. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010811527-2015-00001 |
| MDR Report Key | 4641425 |
| Report Source | 05 |
| Date Received | 2015-03-26 |
| Date of Report | 2015-03-26 |
| Date Added to Maude | 2015-03-31 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 10300 ENTERPRISE DR. |
| Manufacturer City | MEQUON WI 53092 |
| Manufacturer Country | US |
| Manufacturer Postal | 53092 |
| Manufacturer Phone | 2622368478 |
| Manufacturer G1 | FUZHOU JUMPER SHOES CO LTD |
| Manufacturer Street | NO 1 INDUSTRIAL REGION FUXING INVESTMENT AREA |
| Manufacturer City | GUSHAN 350014 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 350014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR COMFORT |
| Generic Name | PERFORMANCE BLK/GRY |
| Product Code | FMP |
| Date Received | 2015-03-26 |
| Model Number | 7610-W-11.5 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2015-03-26 |