MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-03-01 for CPM manufactured by Djo, Llc.
[39367409]
Patient Sequence No: 1, Text Type: N, H10
[39367410]
Service of summons was manufacturers first notification of this event. Plaintiffs counsel claims in the complaint that "plaintiff suffered a ruptured patellar tendon after following instructions which caused knee injury, multiple surgeries, multiple hospitalizations, pain, suffering, permanent disfigurement, medical specials, lost earnings, loss of earnings capacity, costs, future medical specials and billing". Questionnaire not received from clinician and/or patient. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2016-00005 |
| MDR Report Key | 5470466 |
| Report Source | OTHER |
| Date Received | 2016-03-01 |
| Date of Report | 2016-03-01 |
| Date of Event | 2014-02-14 |
| Date Mfgr Received | 2016-02-19 |
| Date Added to Maude | 2016-03-01 |
| 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 |
| Generic Name | CPM |
| Product Code | BXB |
| Date Received | 2016-03-01 |
| 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 | 2016-03-01 |