MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-12 for DR COMFORT 37725-X-08.5 manufactured by Dr Comfort, A Djo, Llc Company.
[110761842]
Complaint received that alleges "the shoes katy green/turquoise 08. 5 xw caused her an infection that will lead to amputation of her left foot".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2018-00004 |
| MDR Report Key | 7591854 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-12 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-05-31 |
| Date Added to Maude | 2018-06-12 |
| 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 | 1460 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer G1 | DR COMFORT, A DJO, LLC COMPANY |
| Manufacturer Street | 10300 ENTERPRISE DRIVE |
| Manufacturer City | MEQUON CA 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 | KATY GREEN/TURQUOISE 8 1/2 XWI |
| Product Code | KNP |
| Date Received | 2018-06-12 |
| Model Number | 37725-X-08.5 |
| 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 DRIVE MEQUON CA 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-06-12 |