MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-09-17 for AIRCAST 01P-XL manufactured by Djo, Llc.
[3717901]
Complaint rec'd stating that the plaintiff "was wearing boot during therapy. Pt has diabetic neuropathy and does not feel pain in this part of his leg. During therapy his skin was being lacerated and he was unable to feel that his skin was being damaged. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2013-00015 |
| MDR Report Key | 3367808 |
| Report Source | 04 |
| Date Received | 2013-09-17 |
| Date of Report | 2013-09-17 |
| Date of Event | 2013-08-07 |
| Date Added to Maude | 2013-09-26 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA 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 | AIRCAST WALKER BOOT |
| Product Code | IPG |
| Date Received | 2013-09-17 |
| Model Number | 01P-XL |
| 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 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-17 |