MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-02-20 for AIRCAST 01EP-L manufactured by Djo, Llc.
[100453008]
Complaint received that alleges "walker makes a problem on the surgical wounds by sharp edges, patient now gets intravenous antibiotics due to an infection". Questionnaire not received from customer or clinician. Device not received manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2018-00001 |
| MDR Report Key | 7282977 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-02-20 |
| Date of Report | 2018-02-20 |
| Date of Event | 2018-02-12 |
| Date Added to Maude | 2018-02-20 |
| 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 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 | AIRSELECT, ELITE, LARGE |
| Product Code | ITW |
| Date Received | 2018-02-20 |
| Model Number | 01EP-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 | 2018-02-20 |