MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-26 for * SAC22 P G/N/L manufactured by Innovative Products Unlimited, Inc.
[16553385]
Patient placed into bedside commode (bsc), positioned leg in anticipation of painful spasm, and nursing assistant tried to accommodate by repositioning bsc. When she repositioned, components of pvc material dislodged, causing collapse of chair. What was the original intended procedure? Bedside commode for bowel movement. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3259342 |
| MDR Report Key | 3259342 |
| Date Received | 2013-07-26 |
| Date of Report | 2013-07-19 |
| Date of Event | 2013-07-17 |
| Report Date | 2013-07-19 |
| Date Reported to FDA | 2013-07-26 |
| Date Reported to Mfgr | 2013-08-01 |
| Date Added to Maude | 2013-08-01 |
| 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 | 3 |
| 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 | * |
| Generic Name | CHAIR |
| Product Code | INB |
| Date Received | 2013-07-26 |
| Model Number | SAC22 P G/N/L |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVATIVE PRODUCTS UNLIMITED, INC |
| Manufacturer Address | 2120 INDUSTRIAL DRIVE NILES MI 49120 US 49120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-26 |