ROLLATOR 20 IN 250LB 5 IN WHEELS
Received Aug 16, 2021 · Event occurred Apr 14, 2021
Report 1423537-2021-00662 · MDR key 12328859
Device
Generic name
Walker, Mechanical
Manufacturer
Jan Mao Industries Co., Ltd.Model number
CRL0008RCatalog number
CRL0008R
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- Fall
- Laceration(s)
- Fall
- Laceration(s)
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD FOR THE REPORTED PRODUCT COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. THIS IS THE FIRST COMPLAINT REPORTED ON THIS PRODUCT FOR THIS TYPE OF ISSUE IN THE PAST TWELVE MONTHS. ACCORDING TO SUPPLIER, THERE WERE NO CHANGES TO DESIGN, PRODUCTION PROCESS, OR RELATED MATERIALS. THE COMPLAINT SAMPLE AND LOT NUMBER WERE NOT AVAILABLE FOR INVESTIGATION; THEREFORE, THE SUPPLIER WAS UNABLE TO DETERMINE THE ROOT CAUSE. THE SUPPLIER WILL CONTINUE TO MONITOR TRENDS FOR THIS TYPE OF INCIDENT.
Description of Event or Problem
PLAINTIFF ALLEGES ¿THE ROLLATOR SUDDENLY AND UNEXPECTEDLY BROKE DROPPING MS. (B)(6) ONTO THE FLOOR AND THE METAL OF THE BROKEN ROLLATOR SLICED HER ARM AS SHE FELL REQUIRING A THREE-DAY HOSPITAL STAY. MS. (B)(6) HAD USED THE ROLLATOR FOR LESS THAN TWO MONTHS WHEN THIS PRODUCT MALFUNCTION OCCURRED.¿