MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for UNKNOWN manufactured by Djo, Llc.
[59557894]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[59557895]
Plaintiffs counsel claims in the complaint that "physical therapy negligently attached a strap, which was part of a traction device, to plaintiff head and proceeded to perform traction therapy upon plaintiff's cervical spine, however, the strap came undone, thereby causing plaintiff's head to suddenly jerk which caused plaintiff to suffer injuries and damages. As a result of said negligence of defendants, plaintiff was injured in plaintiff's health, strength and activity sustaining injury to plaintiff's body and shock and injury to plaintiff's nervous system and person, all of which said injuries have caused and continue to cause plaintiff great mental, physical, and nervous pain and suffering. Plaintiff is informed and believes and thereon alleges that said injuries will result in some permanent damage. " questionnaire not received from clinician and/or patient. Device not returned to manufacturer for evaluation. The summons does not state if a djo device was in use at time of incident of if any djo device was used at any time during treatment of this patient/plaintiff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2016-00027 |
| MDR Report Key | 6090714 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-11-09 |
| Date of Event | 2012-09-27 |
| Date Mfgr Received | 2016-10-31 |
| Date Added to Maude | 2016-11-09 |
| 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 | 0 |
| Brand Name | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | ILZ |
| Date Received | 2016-11-09 |
| 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 | 2016-11-09 |