FDA Adverse Event Injury Summary report: N

INX FOR INLINE WITH DWL

MDR report key: 12762993 · Received November 7, 2021

Report

Report Number
1523574-2021-00016
Event Type
Injury
Date Received
November 7, 2021
Date of Event
October 22, 2021
Report Date
November 5, 2021
Manufacturer
FERNO-WASHINGTON, INC.
Product Code
FPO
UDI-DI
00019090001339
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
SC, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE WAS EVALUATED BY THE CUSTOMER WITH NO PRODUCT ISSUES FOUND. THE PATIENT ALLEGED INJURY IS BEING ATTRIBUTED TO THE MOTOR VEHICLE ACCIDENT. NO FURTHER DETAILS WERE PROVIDED.

Description of Event or Problem · 0

THE CUSTOMER REPORTED THE STRETCHER WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT WHILE TRANSPORTING A PATIENT. THE CUSTOMER ADVISED THE STRETCHER REMAINED LOCKED WITHIN THE FASTENER THROUGHOUT THE ACCIDENT. THERE HAS BEEN NO ALLEGATION OF A PRODUCT MALFUNCTION. THE PATIENT IS ALLEGING BACK PAIN, SOLELY, AS A RESULT OF THE MOTOR VEHICLE ACCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1655215 INX FOR INLINE WITH DWL INX FOR INLINE WITH DWL FPO FERNO-WASHINGTON, INC. 0015811 00019090001339

Patients

Seq Age Sex Outcome Treatment
1 Unknown Other