MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-22 for 17-0004-0-00000 manufactured by Djo, Llc.
[83293270]
Complaint received that alleges "toe filler came apart, pt has been to wound care. Device caused a blister at the end of the stump amputation". Questionnaire not received from customer or clinician. Device was received by manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2017-00005 |
| MDR Report Key | 6811820 |
| Report Source | CONSUMER |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-08-01 |
| Date Added to Maude | 2017-08-22 |
| 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 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 |
| Generic Name | L5000 TOE FILLER CUSTOM INSOLE |
| Product Code | KYS |
| Date Received | 2017-08-22 |
| Catalog Number | 17-0004-0-00000 |
| 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 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-22 |