FDA Adverse Event Injury Summary report: N

SUNMARK FOREARM CRUTCH ADULT

MDR report key: 6011786 · Received October 7, 2016

Report

Report Number
1451040-2016-00001
Event Type
Injury
Date Received
October 7, 2016
Date of Event
September 12, 2016
Report Date
October 7, 2016
Manufacturer
JAN MAO INDUSTRIES CO., LTD.
Product Code
IPR
Product Problem
Yes
Report Source
Distributor report
Reporter Location
MD, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON 09/13/2016, A COMPLAINT WAS RECEIVED FROM AN EMPLOYEE OF (B)(6) DRUG STORE WHO CLAIMED THAT A CUSTOMER RETURNED TO THE DRUG STORE ON (B)(6) 2016 WITH A PAIR OF FOREARM CRUTCHES, ONE OF WHICH WAS BROKEN IN HALF. BASED ON THE PICTURES SENT TO US BY THE COMPLAINANT, IT APPEARS THAT THE CRUTCH IS BROKEN AT THE UPPER MOST PRE-DRILLED HOLE USED FOR THE PUSH BUTTON ADJUSTMENT. THE COMPLAINANT REPORTED THAT THE CRUTCHES WERE PURCHASED FROM (B)(6) IN (B)(6) 2016. THE COMPLAINANT ALSO STATED THAT THE CUSTOMER ALLEGED THAT HE FELL, ALTHOUGH NO INJURY OCCURRED. WE FOLLOWED UP WITH THE COMPLAINANT ON 09/27/2016 IN ORDER TO COLLECT INFORMATION FOR THIS REPORT. THE COMPLAINANT INDICATED THAT THE CRUTCHES IN QUESTION WERE PURCHASED FROM (B)(6) ON (B)(6) 2016. WE FOLLOWED UP WITH THE MANUFACTURER ON 09/27/2016 AND BASED ON THE SERIAL NUMBER OF THE CRUTCHES IN QUESTION, THE MANUFACTURER ADVISED THAT THE CRUTCHES WERE MANUFACTURED 01/13/2016.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
662854 SUNMARK FOREARM CRUTCH ADULT FOREARM CRUTCH IPR JAN MAO INDUSTRIES CO., LTD.

Patients

Seq Age Sex Outcome Treatment
1 50 YR Required Intervention