BRODA CHAIR BR-RP17601154

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-22 for BRODA CHAIR BR-RP17601154 manufactured by Broda Seating.

Event Text Entries

[2521522] Resident is (b)(6) old female that was admitted here on (b)(6) 2011. She has both receptive and expressive communication difficulties. She only sometimes understood and sometimes understands. She requires extensive assistance with most adls. She is able to ambulate very short distances with extensive assistance of 2 staff members. Resident was up in broda chair this a. M. With bilateral leg rests and foot calf combo on the chair. Resident had attended a visit to the podiatrist earlier in the a. M. And was somewhat agitated at that time but receives a routine ativan with the a. M. Med pass. At 1015, the nurse was called to see the resident because, the foot calf combo on her chair was covered with blood and there was an open area noted on her leg. Resident was assessed by an rn and there was a very large open area noted on the residents left inner shin/leg. There was a skin flap on part of the area but some of the skin was removed from the area and subcutaneous tissue was noted. Pressure was applied to the area to stop from bleeding. Upon investigation of the incident, it was noted that the foot rests on the broda chair had exposed bolts and a piece of the resident's skin was attached to one of the bolts. The resident had thrown her legs over the side of the chair and this caused the injury. The physician was notified of the incident and she was sent to the emergency room for evaluation. Resident returning this afternoon with dissolvable stitches and an order for treatment to th area. All the wheelchairs are being qa'd for exposed bolts and will have hardware padded as appropriate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5024373
MDR Report Key2468883
Date Received2012-02-22
Date of Report2012-02-22
Date of Event2012-02-10
Date Added to Maude2012-02-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBRODA CHAIR
Generic NameBRODA CHAIR LEG REST ELEVATORS
Product CodeFRJ
Date Received2012-02-22
Model NumberBR-RP17601154
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerBRODA SEATING
Manufacturer Address560 BINGEMAN'S CENTER DR. KITCHENER, ONTARIO N2B3X9 CA N2B3X9


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-02-22

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