MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-08-05 for DR. COMFORT 2040-X-07.5 manufactured by Dr Comfort, A Djo Llc Company.
[33475423]
Complaint received via summons that alleges "shoes caused ulceration, wounds, and/or infection on rt foot and toes. As a direct and proximate result of defendants' negligence and ineffective design, manufacture, distribution, alteration, or modification of the shoes and inserts, mrs (b)(6) right foot had been damaged to the point that she was hospitalized on (b)(6) 2013 with a limb threatening osteomyelitis, gas gangrene, and infection of her right foot, necessitating extensive and substantial medical treatment, surgeries, and the partial amputation of her right foot. " questionnaire was not received from clinician and/or patient. Device not returned to manufacturer for evaluation. See scanned page.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2015-00002 |
| MDR Report Key | 5292479 |
| Report Source | OTHER |
| Date Received | 2015-08-05 |
| Date of Report | 2015-08-04 |
| Date of Event | 2013-08-18 |
| Date Mfgr Received | 2015-07-13 |
| Date Added to Maude | 2015-12-14 |
| 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 | 10300 ENTERPRISE DRIVE |
| Manufacturer City | MEQUON WI 53092 |
| Manufacturer Country | US |
| Manufacturer Postal | 53092 |
| Manufacturer Phone | 2622368478 |
| Manufacturer G1 | SHINY GROUP INTL, LLC |
| Manufacturer Street | WEST SOUTH ROAD, CHANG KENG LIAO BU TOWN |
| Manufacturer City | DON GUAN CITY, CN-44 523400 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 523400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DR. COMFORT |
| Generic Name | LINDSEY WHITE SHOE |
| Product Code | KNP |
| Date Received | 2015-08-05 |
| Model Number | 2040-X-07.5 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR COMFORT, A DJO LLC COMPANY |
| Manufacturer Address | 10300 ENTERPRISE DERIVE MEQUON WI 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-08-05 |