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Adverse Event Report

BASIC AMERICAN METAL PRODUCTS BAMP 3/4 LENGTH SWING DOWN RAIL BED RAIL   back to search results
Model Number 554-0433-000
Event Type  Other   Patient Outcome  Other;
Event Description

Pt/unk fell from bed, breaking one rib.

 
Manufacturer Narrative

Source notified basic american metal products of incident by letter 12/1/1998. Basic american metal products' rep spoke with regulatory affairs person who advised the facility experienced repetitive problems with a side rail then the rail falling down. One pt had fallen several times and broken one rib. Regulatory affairs also noted that the facility advised that this particular pt moves around a lot, and maybe kicked the button that releases the rail. The staff would put the rail in the up position, checking the rail, assuring it was locked into position. Upon returning to the pt's room, the rail was found in the down position. The source and basic american metal products' rep are attempting to have the rail returned for evaluation and obtain a copy of the facilities incident report. However, at the time of this report, the facility has not honored co's request. Upon receipt of incident details and evaluation of the side rail. Basic american metal products will investigate this incident further, updating this report accordingly.

 
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Brand NameBAMP 3/4 LENGTH SWING DOWN RAIL
Type of DeviceBED RAIL
Baseline Brand NameBAMP 3/4 LENGTH SWING DOWN RAIL
Baseline Generic NameBED RAIL
Baseline Catalogue NumberMEDLINE/MDR101936
Baseline Model Number554-0433-000
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BASIC AMERICAN METAL PRODUCTS
336 trowbridge dr
p.o. box 907
fond du lac WI 54937
Manufacturer (Section D)
BASIC AMERICAN METAL PRODUCTS
336 trowbridge dr
p.o. box 907
fond du lac WI 54937
Manufacturer (Section G)
BASIC AMERICAN METAL PRODUCTS
336 trowbridge rd.
fond du lac WI 54937
Device Event Key195964
MDR Report Key201754
Event Key189531
Report Number2183191-1998-00003
Device Sequence Number1
Product CodeFNJ
Report Source Manufacturer
Source Type Distributor
Reporter Occupation RISK MANAGER
Remedial Action Other
Type of Report Initial
Report Date 12/01/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number554-0433-000
Device Catalogue NumberMEDLINE/MDR101936
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/1998
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on February 28, 2009

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