MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-09-29 for PRONEX CERVICAL TRACTION manufactured by Rs Medical.
[18582466]
Pt reported exacerbation of neck pain during a cervical traction treatment when an accessory flexion wedge slipped out from under the cervical traction headpiece. Pt said he was in pain ever since. Pt described that the accessory flexion wedge slipped out from under the pronex cervical traction assembly with the pt in bed. The flexion wedge or "pad" as the pt described it fell behind the pt's bed. Pt spoke with physician and was told to stop using the device. Pt talking with physician about getting shots or spinal block to address the pain.
Patient Sequence No: 1, Text Type: D, B5
[18739376]
Returned pronex cervical traction device was received on (b)(4) 2010 and was evaluated. The returned device met all applicable performance specs and no problems were found. Additional info later provided determined that the accessory flexion wedge was the part that the pt had described as slipping off and falling behind his bed. The flexion wedge is not positively affixed to the pronex headpiece and is not intended to be. The headpiece is just to rest on the flexion wedge. It is conceivable that the flexion wedge could slip out from under the headpiece but a returned product examination would fail to detect such a circumstance. Mdr filed - (b)(4) 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644243-2010-00011 |
| MDR Report Key | 1854379 |
| Report Source | 04 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-08-30 |
| Date of Event | 2010-08-25 |
| Date Mfgr Received | 2010-08-30 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2011-02-14 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIMOTHY JOHNSON |
| Manufacturer Street | 14001 S.E. FIRST ST. |
| Manufacturer City | VANCOUVER WA 98684 |
| Manufacturer Country | US |
| Manufacturer Postal | 98684 |
| Manufacturer Phone | 3608234940 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRONEX CERVICAL TRACTION |
| Generic Name | CERVICAL TRACTION DEVICE |
| Product Code | ILZ |
| Date Received | 2010-09-29 |
| Returned To Mfg | 2010-09-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RS MEDICAL |
| Manufacturer Address | VANCOUVER WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-29 |