FDA Adverse Event Injury Summary report: N

TRANSPORT CHAIR

MDR report key: 5635121 · Received May 5, 2016

Report

Report Number
1417592-2016-00054
Event Type
Injury
Date Received
May 5, 2016
Date of Event
March 13, 2016
Report Date
May 5, 2016
Manufacturer
MEDLINE INDUSTIRES, INC.
Product Code
INM
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IL, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Additional Manufacturer Narrative · 1

THE END USER'S DAUGHTER REPORTED THAT WHILE SITTING IN THE TRANSPORT CHAIR, THE RIGHT LEG BROKE AND THE END USER FELL. SHE WAS TAKEN TO THE HOSPITAL AND HAD X-RAYS TAKEN OF HER LEGS, SHOULDER AND HIP. SHE WAS DIAGNOSED WITH A FRACTURE IN HER RIGHT CLAVICLE. A SOFT SLING WAS APPLIED AND PAIN MEDICATION GIVEN. SHE WAS DISCHARGED TO HOME. PHOTOS THAT WERE PROVIDED SHOWED THE RIGHT BACKREST TUBE WAS FRACTURED BELOW THE FOLDING MECHANISM. A SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. THE LOT NUMBER HAS NOT BEEN PROVIDED. THE OVERALL CARE AND CONDITION OF THE TRANSPORT CHAIR IS NOT KNOWN. WE HAVE NO INFORMATION TO INDICATE A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE INCIDENT. A ROOT CAUSE HAS NOT BEEN DETERMINED. DUE TO THE REPORTED INJURY, THIS MEDWATCH IS BEING FILED.

Description of Event or Problem · 1

THE END USER'S DAUGHTER REPORTED THAT HER MOTHER WAS SITTING IN THE TRANSPORT CHAIR AND THE RIGHT LEG BROKE AND SHE FELL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
289140 TRANSPORT CHAIR INM MEDLINE INDUSTIRES, INC. UNK

Patients

Seq Age Sex Outcome Treatment
1 87 YR Other