MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-03 for DR COMFORT A5514 SPECIAL ACCOMM CUSTOM INSOLES 17-0002-0-00000 manufactured by Djo, Llc.
[177399471]
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
[177399472]
It was reported that the insert "caused pain or other trauma... Inserts were made from scan but patient's foot seems longer than insert. A wound has now formed on patient's foot... They are doing wound care and wound is healing. " no further information is currently available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008579854-2020-00002 |
| MDR Report Key | 9659571 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-03 |
| 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 75067 |
| Manufacturer Country | US |
| Manufacturer Postal | 75067 |
| Manufacturer G1 | DR. COMFORT, A DJO, LLC COMPANY |
| Manufacturer Street | 10300 ENTERPRISE DR. |
| Manufacturer City | MEQUON WI 59092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 59092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DR COMFORT A5514 SPECIAL ACCOMM CUSTOM INSOLES |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2020-02-03 |
| Returned To Mfg | 2020-02-10 |
| Model Number | 17-0002-0-00000 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-03 |