MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-07-13 for DELUXE TRAPEZE 3071 manufactured by Orthopedic Systems, Inc..
[622184]
As per the hospital representative, the patient was lying in bed using the trapeze to scoot up on the hospital bed. The trapeze sub-component "d" ring failed and part fell onto patient's head. Patient experienced swelling and endured a small abrasion on top of his head.
Patient Sequence No: 1, Text Type: D, B5
[7963696]
The product is designed to withstand a 250 lb patient, the s-hook that failed on the trapeze (master link to connect chain to trapeze and to clamp) is designed to withstand 300 lbs. It appears to be a user error, possibly due to review of device before and after installation on hospital beds.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2007-00002 |
| MDR Report Key | 880637 |
| Report Source | 05 |
| Date Received | 2007-07-13 |
| Date of Report | 2007-02-28 |
| Date of Event | 2007-01-31 |
| Date Mfgr Received | 2007-02-15 |
| Date Added to Maude | 2007-08-10 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAYNE KIRKE |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELUXE TRAPEZE |
| Generic Name | TRACTION |
| Product Code | ILZ |
| Date Received | 2007-07-13 |
| Model Number | 3071 |
| Catalog Number | 3071 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 863024 |
| Manufacturer | ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 945871234 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-13 |