MEDICHOICE
Received May 24, 2023 · Event occurred Mar 15, 2023
Report 3003753847-2023-00001 · MDR key 16994479
Device
Generic name
Medichoice Crutches Aluminum Tall
Manufacturer
Caremax Rehabilitation Equipment Co., LtdModel number
131477710ACatalog number
131477710A
Product problems
- Break
- Break
Patient
Unknown
- Fall
- Fall
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) OF THE PRODUCTION BATCH RECORDS WAS REVIEWED AND NO DEFECTIVE RUBBER TIPS WERE RECORDED. INSPECTION OF THE RETENTION SAMPLES FOUND NO MECHANICAL FAILURE OR QUALITY ISSUE. FROM THE EXAMINATION OF THE SAMPLE RECEIVED, IT WAS DETERMINED THAT THIS WAS AN ISOLATED INCIDENT. IN ADDITION, THE REPORTED INCIDENT HAS BEEN ENTERED IN OUR TRACKING AND TRENDING PROGRAM IN ORDER TO CONTINUOUSLY MONITOR FOR EMERGING TRENDS IN THE MARKETPLACE. OWENS & MINOR DISTRIBUTION INC. HOME-OFFICE IS THE INITIAL IMPORTER OF THIS DEVICE. A SUPPLIER CORRECTIVE ACTION (SCAR) HAS BEEN ISSUED TO THE SUPPLIER TO INVESTIGATE THIS INCIDENT AND ADVISE ON ANY CORRECTIVE ACTIONS TAKEN. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
Additional Manufacturer Narrative
THE PRODUCT INVOLVED IN THE EVENT IS AVAILABLE TO BE RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. OWENS & MINOR DISTRIBUTION INC. HOME-OFFICE IS THE INITIAL IMPORTER OF THIS DEVICE. A SUPPLIER CORRECTIVE ACTION (SCAR) HAS BEEN ISSUED TO THE SUPPLIER TO INVESTIGATE THIS INCIDENT AND ADVISE ON ANY CORRECTIVE ACTIONS TAKEN. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
Description of Event or Problem
REPORTER INDICATED THAT THEY HAD SURGERY ON (B)(6) 2023. THEY WERE PROVIDED MEDICHOICE ALUMINUM CRUTCHES, SERIAL NUMBER (B)(6). THE REPORTER IS THE PATIENT WHO IS 6"2' AND 260LBS. THE CUSTOMER INDICATED THEY WERE THE PERFECT FIT. THE RUBBER TIP OF ONE OF THE CRUTCHES BROKE DURING USE AND THEY FELL, TAKING MULTIPLE HITS TO THEIR BACK, HEAD, AND ANKLE THEY HAD SURGERY ON.