MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-22 for DR COMFORT 7650-W-12.0 manufactured by Dr Comfort, A Djo, Llc Company.
[78179144]
Complaint received that alleges "posterior proximal edge of the heel cup digs into his achilles tendon, it was digging into his tendon every time he took a step or plantar flexed his foot while wearing the shoe. If you look closely you can see that there is a little bit of a difference in the angle from one shoe to the other. He ended up being hospitalized for an infection and he was there for a while". Questionnaire not received from customer or clinician. Device was returned to manufacturer for evaluation. I reviewed the shoes and noticed that the heel counter is smashed down, indicating that the patient walks on the back of the heel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2017-00003 |
| MDR Report Key | 6660325 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-06-12 |
| Date Added to Maude | 2017-06-22 |
| 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 |
| Brand Name | DR COMFORT |
| Generic Name | PERFORMANCE BLUE 12 WIDE |
| Product Code | KNP |
| Date Received | 2017-06-22 |
| Returned To Mfg | 2017-06-16 |
| Model Number | 7650-W-12.0 |
| Lot Number | 6567022 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR COMFORT, A DJO, LLC COMPANY |
| Manufacturer Address | 10300 ENTERPRISE DRIVE MEQUON 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-06-22 |