MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-11 for T.H.E. MEDICAL * manufactured by T.h.e. Medical.
[230206]
Resident was on lift pad after shower. Pt was up in air when the part to upper body lift pad (strap) ripped. Resident fell to floor, hitting head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 399199 |
| MDR Report Key | 399199 |
| Date Received | 2002-06-11 |
| Date of Event | 2002-05-06 |
| Date Facility Aware | 2002-05-06 |
| Report Date | 2002-05-09 |
| Date Added to Maude | 2002-06-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T.H.E. MEDICAL |
| Generic Name | COMBI-SLING |
| Product Code | ILI |
| Date Received | 2002-06-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | PART# 078-9739 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1.5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 388244 |
| Manufacturer | T.H.E. MEDICAL |
| Manufacturer Address | 526 BYRNE DR BARRIE, ONTARIO CA L4N9P6 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-06-11 |