MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-25 for DR COMFORT 4415-M-08.0 manufactured by De Comfort, A Djo, Llc Compant.
[73604105]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[73604106]
Complaint received that alleges "patient was experiencing a ulcer on her left ankle and pain in her left foot from the shoe rubbing. Patient experienced drainage from the wound". Questionnaire not received from customer or clinician. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2017-00001 |
| MDR Report Key | 6518617 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-04-11 |
| Date Added to Maude | 2017-04-25 |
| 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 WI 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 | MERRY JANE LYCRA 8 MED |
| Product Code | KNP |
| Date Received | 2017-04-25 |
| Model Number | 4415-M-08.0 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DE COMFORT, A DJO, LLC COMPANT |
| Manufacturer Address | 10300 ENTERPRISE DRIVE MEQUON WI 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-25 |