N
Patient 1
NOT RETURNED.
MAUDE MDR 6090714
- MDR report key
- 6090714
- Report number
- 9616086-2016-00027
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-09-27
- Date received
- 2016-11-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- WILLIAM FISHER
- Address
- 1430 DECISION STREET VISTA CA 92081 US
- Phone
- 760-760-7607
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-09 | 0 | 1. O |
Event Narratives#
D
Patient 1
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.