MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2013-05-29 for PATIENT HELPER W/LOCKING LEVER 3423 manufactured by Mizuho Orthopedic Systems, Inc..
[45527575]
A pt who had undergone total hip replacement, when recuperating from the surgery in a hill rom versacare bed that had our 3423 mizuho osi patient helper attached to the bed. Two nurses were assisting the patient to reposition himself. During the repositioning, the trapeze that the patient grasped slipped through the "s" hook opening (the "s" hook is at the junction where the chains on the trapeze that also connect to the main adjustable chain that extends down from the patient helper). The trapeze fell and hit the patient on his chest. At that time there was no visible injury to the patient. The nurse complained that she suffered an injury to her previously injured cervical spine. This incident aggravated her previous condition causing her to have cervical spinal surgery to correct the injury. The patient later contacted the hospital and filed a complaint attributing a sore trapezius muscle caused by the failure of the attached trapeze.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2013-00021 |
| MDR Report Key | 5666101 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2013-05-29 |
| Date of Report | 2013-05-14 |
| Date of Event | 2012-12-06 |
| Date Mfgr Received | 2013-05-14 |
| Date Added to Maude | 2016-05-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104291500 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 945871234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT HELPER W/LOCKING LEVER |
| Product Code | KQZ |
| Date Received | 2013-05-29 |
| Model Number | 3423 |
| Catalog Number | 3423 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 945871234 US 945871234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-29 |