MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-04-21 for PROCARE 79-95413 manufactured by Djo, Llc.
[43279068]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[43279069]
Complaint received that alleges "after wearing it for 6 days. Patient's mom states that the rubber sole of the boot unglued and pt. Tripped on it and fell hitting her head this morning. Clinic states patient did not experience pain or injury when fall occurred". Questionnaire not received from clinician and/or patient. Device not returned to manufacturer for evaluation. No indication event caused or contributed to permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2016-00012 |
| MDR Report Key | 5595825 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-04-21 |
| Date of Report | 2016-04-20 |
| Date of Event | 2016-04-05 |
| Date Mfgr Received | 2016-04-08 |
| Date Added to Maude | 2016-04-21 |
| 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 | PROCARE |
| Generic Name | MAXTRAX AIR WALKER,S |
| Product Code | IPG |
| Date Received | 2016-04-21 |
| Model Number | 79-95413 |
| 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 | 2016-04-21 |