MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-04-04 for PATIENT HELPER ADAPTER (HEIGHT ADJ) 00-0965-002-01 manufactured by Zimmer Surgical.
[20000294]
It was reported that the sleeve section of the pt helper bent where it attaches to the bed bracket. Additional clinical follow up with the hospital indicated that the pt helper had been on the pt's bed providing trapeze use for quite some time. The rn stated the pt was considered to be quite proactive with physical therapy and self exercise to regain limb function and strength. The rn stated the pt was "doing chin-ups on the trapeze, lifting his full body weight completely off the bed, when the pt noted the bar to be bending slightly over the bed. " the rn stated the pt was not harmed and neither the trapeze no the pt helper fell.
Patient Sequence No: 1, Text Type: D, B5
[20279322]
The device was not returned to the manufacturer at the time of this report. A follow up medwatch will be submitted once the device has been returned and the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1035617-2012-00002 |
| MDR Report Key | 2521021 |
| Report Source | 05,08 |
| Date Received | 2012-04-04 |
| Date of Report | 2012-03-07 |
| Date of Event | 2012-03-01 |
| Date Mfgr Received | 2012-03-07 |
| Date Added to Maude | 2012-09-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CINDY DICKEY |
| Manufacturer Street | 1872 OLD MOUNTAIN RD. |
| Manufacturer City | STATESVILLE NC 28625 |
| Manufacturer Country | US |
| Manufacturer Postal | 28625 |
| Manufacturer Phone | 7048731001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT HELPER ADAPTER (HEIGHT ADJ) |
| Generic Name | PATIENT HELPER ADAPTER (HEIGHT ADJ) |
| Product Code | ILZ |
| Date Received | 2012-04-04 |
| Model Number | NA |
| Catalog Number | 00-0965-002-01 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL |
| Manufacturer Address | 1872 OLD MOUNTAIN RD. STATESVILLE NC 28625 US 28625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-04 |