MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-10 for AIRCAST 01P-S manufactured by Djo, Llc.
[30983033]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[30983034]
Complaint received that alleges "walker used for 3 months, now: complaint about damage of the nerve, toes numb (permanent), prescribing doctor says the walker was not correct". Questionnaire was received from clinician and/or patient, prescribed different device is only treatment required/listed for 2 toes numb/nerve damage. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2015-00030 |
| MDR Report Key | 5215299 |
| Date Received | 2015-11-10 |
| Date of Report | 2015-11-10 |
| Date of Event | 2015-04-18 |
| Date Mfgr Received | 2015-12-29 |
| Date Added to Maude | 2015-11-10 |
| 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 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 | AIRCAST |
| Product Code | IPG |
| Date Received | 2015-11-10 |
| Model Number | 01P-S |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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. Deathisabilit | 2015-11-10 |