MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-10 for AE-3 ADAPTA '97 ADP300 manufactured by Djo, Llc.
[15197808]
Pt was using the table to stretch her knee into flexion. The table dropped to its bottom limit, approximately six to ten inches, which forced the pt's knee into flexion. Pt's preexisting condition include total knee replacement and 3 knee surgeries in the last year. She sought further medical treatment and saw a doctor in the er. Her upper left shoulder, cervical area, lower back, and left knee was x-rayed. Results from x-rays unk. Potential service of summons and complaint. The company has been unable to inspect the device. Because the matter is potentially in litigation, it has been turned over to outside counsel for further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-2011-00012 |
| MDR Report Key | 2338128 |
| Report Source | 05 |
| Date Received | 2011-11-10 |
| Date of Report | 2011-11-10 |
| Date of Event | 2011-10-04 |
| Date Mfgr Received | 2011-10-12 |
| Date Added to Maude | 2011-11-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | CONTRACT INDUSTRIAL TOOLING (CIT) |
| Manufacturer Street | 2351 PRODUCTION COURT |
| Manufacturer City | RICHMOND IN 47374 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47374 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AE-3 ADAPTA '97 |
| Generic Name | TRACTION POWERED - TABLES AND TRACTION |
| Product Code | ITH |
| Date Received | 2011-11-10 |
| Model Number | ADP300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1930 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-11-10 |