MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-11-06 for AIRCAST 01ES-L manufactured by Djo, Llc.
[126304927]
It was reported that the patient went to the emergency room (er) because of severe fungus on the bottom of her foot, reportedly due to excessive moisture accumulating in the bottom of the boot and in the air bladders. "she was going in for bunion surgery but the fungus was on the heel of her foot. " there was no indication of what or if any treatment was performed on the fungus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2018-00024 |
| MDR Report Key | 8043583 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-11-06 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2018-05-30 |
| Date Added to Maude | 2018-11-06 |
| 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 | BRIAN BECKER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| 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 | JOINT, ANKLE, EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2018-11-06 |
| Model Number | 01ES-L |
| Lot Number | 180530-BB |
| 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. Hospitalization | 2018-11-06 |