MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-19 for PATIENT HELPER FRAME HILL-ROM 00-0965-001-00 manufactured by Zimmer Orthopaedic Surgical Products.
[18576940]
Account states that the patient helper, when loosened, slid down the adaptor tube and the trapeze bar came in contact with the patient's head. No patient injury or medical care was required.
Patient Sequence No: 1, Text Type: D, B5
[18592207]
Device was not returned for evaluation. Zimmer osp contacted risk manager at account to gather additional details of the event. Risk manager stated that the hospital had modified the device because the patient helper bar slid down the adaptor tube and the trapeze bar came in contact with the patient's head, no injury reported. Zimmer stated that the device is currently under recall and the device should be returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1035617-2008-00011 |
| MDR Report Key | 1172711 |
| Report Source | 05 |
| Date Received | 2008-09-19 |
| Date of Report | 2008-08-13 |
| Date Facility Aware | 2008-08-13 |
| Report Date | 2006-08-13 |
| Date Reported to Mfgr | 2008-08-13 |
| Date Mfgr Received | 2008-08-13 |
| Date Added to Maude | 2010-04-15 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | DEBARA REESE |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303649483 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1526350-07/03/2008-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT HELPER FRAME HILL-ROM |
| Generic Name | PATIENT HELPER FRAME HILL-ROM |
| Product Code | ILZ |
| Date Received | 2008-09-19 |
| Catalog Number | 00-0965-001-00 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | 2021 OLD MOUNTAIN ROAD STATESVILLE NC 28677 US 28677 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-19 |