MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD DRIVE; CRUTCHES

Model Number 10402-1

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Date 01/09/2021

Event Type  malfunction  

Event Description

(b)(6) healthcare was notified of an incident involving a crutch reported to be "defective," and "appears to have snapped." the end user reported exacerbation of a broken foot.Drive attempted but was not able to retrieve the products for evaluation.

• Brand Name: DRIVE
• Type of Device: CRUTCHES
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; 98, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 15058044
• MDR Text Key: 296214094
• Report Number: 2438477-2022-00050
• Device Sequence Number: 1
• Product Code: IPR
• UDI-Device Identifier: 00822383126609
• UDI-Public: 822383126609
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10402-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2022
• Distributor Facility Aware Date: 01/12/2022
• Event Location: Home
• Date Report to Manufacturer: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 109 KG