MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-04-25 for CPM OPTIFLEX-S SHOULDER BLK 2029 manufactured by Djo, Llc.
[2748985]
The legal complaint alleges that cpm chair broke with the plaintiff's left arm strapped in the elevated position, which caused her arm to fall sharply against the chair resulting in serious and permanent injuries. Mfr's initial notification of this event was the legal complaint that was served on the registered agent for djo, llc on march 28, 2012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2012-00027 |
| MDR Report Key | 2552587 |
| Report Source | 99 |
| Date Received | 2012-04-25 |
| Date of Report | 2012-04-25 |
| Date of Event | 2007-01-30 |
| Date Mfgr Received | 2012-03-28 |
| Date Added to Maude | 2012-05-01 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| 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 | CPM OPTIFLEX-S SHOULDER BLK |
| Generic Name | CPM |
| Product Code | BXB |
| Date Received | 2012-04-25 |
| Model Number | 2029 |
| 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 ST VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-25 |