MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-02 for DR COMFORT CLASSIC BLACK 10 XWIDE 8410-X-10.0 manufactured by Djo, Llc.
[184332381]
No device was returned for evaluation. If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Patient Sequence No: 1, Text Type: N, H10
[184332382]
It was reported that the patient "suffered... Foot ulcers on the heels of both feet... Not only did (patient) suffer from foot ulcers, he was left with the shoe impression embedded on both feet. This also caused, improper and negligent amputation of his big toe, and huge gashes to the heels of the bottom of both of his feet. " no further information is currently available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2020-00006 |
| MDR Report Key | 9777342 |
| Report Source | OTHER |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-29 |
| Date of Event | 2019-07-29 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-02 |
| 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 | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE, TX |
| Manufacturer Country | US |
| Manufacturer G1 | DR. COMFORT, A DJO, LLC COMPANY |
| Manufacturer Street | 10300 ENTERPRISE DR. |
| Manufacturer City | MEQUON, WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR COMFORT CLASSIC BLACK 10 XWIDE |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2020-03-02 |
| Model Number | 8410-X-10.0 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-02 |