FDA Adverse Event Injury Summary report: N

PROBASICS

MDR report key: 17443967 · Received August 2, 2023

Report

Report Number
3012316249-2023-00028
Event Type
Injury
Date Received
August 2, 2023
Date of Event
June 2, 2023
Report Date
August 2, 2023
Manufacturer
JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
Product Code
IMM
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

PATIENT ATTEMPTED TO AMBULATE AND GOT HER FEET CAUGHT IN THE FOOTREST OF THE WHEELCHAIR FALLING FORWARD RESULTING IN PELVIC FRACTURE REQUIRING SURGICAL INTERVENTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1467468 PROBASICS K2 WHEELCHAIR, 18X16 W/SAFR IMM JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. WC21816DS

Patients

Seq Age Sex Outcome Treatment
1 88 YR Female Required Intervention| H