FDA Adverse Event Other Summary report: N

WHEELCHAIR

MDR report key: 17316302 · Received July 12, 2023

Report

Report Number
MW5119339
Event Type
Other
Date Received
July 12, 2023
Report Date
June 29, 2023
Manufacturer
MEDLINE INDUSTRIES, LP - NORTHFIELD
Product Code
IOR
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
OTHER
Health Professional
*

Narratives

Description of Event or Problem · 0

(B)(6) WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH (B)(6) IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED A MANUFACTURER MEDLINE WHEELCHAIR, SERIAL NUMBER (B)(6) THAT HAD REDUCED BRAKE FORCE. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1715185 WHEELCHAIR WHEELCHAIR, MECHANICAL IOR MEDLINE INDUSTRIES, LP - NORTHFIELD

Patients

Seq Age Sex Outcome Treatment
1 Unknown