MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-07-01 for DR COMFORT 9410-M-09.0 manufactured by Dr. Comfort, A Djo, Llc Company.
[4750696]
Complaint received via court summons that alleges "patient suffers from the disease of diabetes mellitus. On the first day that the patient wore the dr. Comfort boots which he obtained thru truarch, he was shocked to learn that he had developed a significant blister on his right heel. (b)(6) was unaware of the development of this blister as it occurred due to the foot neuropathy from which he suffers as a result of his medical condition. Because of the development of this blister and its ensuing consequences, (b)(6) was required by his treating physicians to endure a lengthy hospital stay and continued wound care treatment, and will be unable to wear a shoe on his right foot for at least a year".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010811527-2014-00001 |
| MDR Report Key | 3975148 |
| Report Source | 04 |
| Date Received | 2014-07-01 |
| Date of Report | 2014-06-30 |
| Date of Event | 2014-04-01 |
| Date Added to Maude | 2014-08-05 |
| 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 | RANGER |
| Product Code | FMP |
| Date Received | 2014-07-01 |
| Model Number | 9410-M-09.0 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization | 2014-07-01 |