MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-28 for AIRCAST 01EP-M manufactured by Djo, Llc.
[81292169]
Complaint received that alleges "large wound at heel, wounded skin is softened and white with black frame, looks like after a long bath, maceration". Questionnaire was received from customer or clinician. Clinician had directed patient wear the walker 14 days without opening, lay down the foot very often, not to walk too much, wear the white sock. Device not reviewed by manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2017-00014 |
| MDR Report Key | 6750652 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-28 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-07-04 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-07-28 |
| 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 | 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 | 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 | AIRSELECT, ELITE, MEDIUM |
| Product Code | ITW |
| Date Received | 2017-07-28 |
| Returned To Mfg | 2017-08-31 |
| Model Number | 01EP-M |
| 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 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-28 |