MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-01-28 for AIRCAST 01PD-L manufactured by Djo, Llc.
[37014968]
Not returned
Patient Sequence No: 1, Text Type: N, H10
[37014969]
Complaint received that alleges "he suffered an injury to the bottom of his foot where the impax grid was used to unload an area of discomfort, and after 2 days of wear the area was split open. The patient is diabetic and so he called his hospital to let them know and they were unable to assist him nad just told him to stop wearing the boot. This was approximately 5-6 months ago". Questionnaire was not received from clinician and/or patient. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2016-00003 |
| MDR Report Key | 5396491 |
| Report Source | CONSUMER |
| Date Received | 2016-01-28 |
| Date of Report | 2016-01-28 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2016-01-18 |
| Date Added to Maude | 2016-01-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, MEXICO 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRCAST |
| Generic Name | XP DIABETIC WALKER |
| Product Code | IPG |
| Date Received | 2016-01-28 |
| Model Number | 01PD-L |
| 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. Other | 2016-01-28 |