MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-07-10 for COMPEX 2540660 manufactured by Djo, Llc.
[79571524]
Plaintiffs counsel claims in the complaint that "electrode stimulation proved to be dangerously high, causing mr. (b)(6)'s bicep to forcefully and unnaturally contract to a dangerous degree and proceeded to injure our client. Impression: rotator cuff tendinosis with mild intrasubstance partial tearing. There is no full thickness tear present. Mild subacromial and subdeltoid bursitis. There is a complete tear of the biceps tendon with the proximal portion of the biceps extending anteriorly and superior to the subscapularis muscle bundle. Superior labral tearing. Glenohumeral joint effusion. Acromioclavicular joint hypertrophy and inflammation". 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 | 9616086-2017-00011 |
| MDR Report Key | 6697220 |
| Report Source | OTHER |
| Date Received | 2017-07-10 |
| Date of Report | 2017-07-10 |
| Date of Event | 2016-09-17 |
| Date Added to Maude | 2017-07-10 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPEX |
| Generic Name | COMPEX WIRELESS USA COMPLETE SET |
| Product Code | NGX |
| Date Received | 2017-07-10 |
| Model Number | 2540660 |
| 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 | 2017-07-10 |