MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-14 for MULTIMATE * manufactured by Simmons Healthcare, Inc..
[20682448]
Resident was observed sitting up in bed shaking side rail then was attempting to crawl over side rail. Had shaken the latch arm and while climbing over side rail the side rail gave way and resident fell to floor. Sustained a laceration to forehead. Pt's arm was under the side rail. Sutures were done to forehead. X-rays (l) forearm - no tx noted; bruising only.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1010556 |
MDR Report Key | 61950 |
Date Received | 1997-01-14 |
Date of Report | 1997-01-03 |
Date of Event | 1996-11-29 |
Date Added to Maude | 1997-01-15 |
Event Key | 0 |
Report Source Code | Voluntary 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 | 0 |
Report to FDA | 0 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MULTIMATE |
Generic Name | MANUAL HOSPITAL BED |
Product Code | INY |
Date Received | 1997-01-14 |
Model Number | * |
Catalog Number | * |
Lot Number | * |
ID Number | * |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 62288 |
Manufacturer | SIMMONS HEALTHCARE, INC. |
Manufacturer Address | 2935 NORTHEAST PKWY ATLANTA GA 30360 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1997-01-14 |