MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-09 for DR COMFORT 6310-X-13.0 manufactured by Dr Comfort, A Djo, Llc Company.
[107769973]
Complaint received that alleges "right foot beginning to ulcer with drainage by the 4th and 5th met pad". Questionnaire not received from customer or clinician. Device not received manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2018-00003 |
| MDR Report Key | 7499695 |
| Report Source | CONSUMER |
| Date Received | 2018-05-09 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-05-07 |
| Date Added to Maude | 2018-05-09 |
| 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 | WILLIAM FISHER |
| 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 DRIVE |
| Manufacturer City | MEQUON 53092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR COMFORT |
| Generic Name | GSA WILLIAM BLACK 13 XWIDE |
| Product Code | KNP |
| Date Received | 2018-05-09 |
| Returned To Mfg | 2018-05-07 |
| Model Number | 6310-X-13.0 |
| Lot Number | FY--53--16 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 DRIVE MEQUON 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-09 |