MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-30 for TRT-200 manufactured by Djo, Llc.
[22041469]
Complaint received alleging "outpatient sat on physical therapy treatment table when it was in low position. After she sat/laid down the table began to elevate, and continued to rise. Pt fell off the table, was stabilized and sent to the emergency department where she was treated for a dislocated shoulder and fractured arm due to the fall. " initial notification of complaint was a copy of user facility form fda 3500a report number (b)(4). No additional information supplied to us for evaluation. Product not returned to us for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-2013-00001 |
| MDR Report Key | 2956728 |
| Report Source | 05 |
| Date Received | 2013-01-30 |
| Date of Report | 2013-01-30 |
| Date of Event | 2012-11-08 |
| Date Mfgr Received | 2013-01-02 |
| Date Added to Maude | 2013-02-14 |
| 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 STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 760271280 |
| Manufacturer G1 | CONTRACT INDUSTRIAL TOOLING |
| 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 |
| Generic Name | PHYSICAL THERAPY TABLE |
| Product Code | JFB |
| Date Received | 2013-01-30 |
| Model Number | TRT-200 |
| 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 | 1430 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-01-30 |