MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-05-16 for TRAPEZE, HEAVY DUTY 00-0640-003-00 manufactured by Zimmer Surgical.
[3453452]
It was reported that the patient used the trapeze to assist in sitting up in the bed. The trapeze "o" ring broke and hit the patient in the head. Additional clinical follow up with the customer indicated that the patient received minimal laceration as result of reported event.
Patient Sequence No: 1, Text Type: D, B5
[10741278]
The device was not returned to the mfr at the time of this report. A follow up medwatch will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526350-2013-00251 |
| MDR Report Key | 3122016 |
| Report Source | 05,07 |
| Date Received | 2013-05-16 |
| Date of Report | 2013-04-19 |
| Date of Event | 2013-04-01 |
| Date Mfgr Received | 2013-04-19 |
| Date Added to Maude | 2013-05-22 |
| 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 | 200 WEST OHIO AVE. |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303438801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAPEZE, HEAVY DUTY |
| Generic Name | TRAPEZE, HEAVY DUTY |
| Product Code | ILZ |
| Date Received | 2013-05-16 |
| Model Number | NA |
| Catalog Number | 00-0640-003-00 |
| Lot Number | UNKNOWN |
| 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 | 200 WEST OHIO AVE. DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-16 |