MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL INSTRUMEN DRIVE; CRUTCH

Model Number 10402-1

Device Problem Break (1069)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Type  Injury  

Event Description

On (b)(6) 2022, (b)(4) healthcare was notified of an incident involving a pair of crutches.The end-user stated that "after two days" of use following foot surgery, "the plastic piece towards the bottom of the crutches snapped in half," "resulting in the bottom piece to move to the side in a "v" angle," causing him to "fall on the floor and reinjure [his] already broken foot and injured knee," and causing "a new large welt on the upper side" of his right leg.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it.

• Brand Name: DRIVE
• Type of Device: CRUTCH
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMEN; 98, zhaoyi road,; dongsheng town,; zhongshan city,, guangdong, 52841 4; CH 528414
• MDR Report Key: 14105581
• MDR Text Key: 289220514
• Report Number: 2438477-2022-00029
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10402-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2022
• Distributor Facility Aware Date: 02/24/2022
• Device Age: 15 MO
• Event Location: Home
• Date Report to Manufacturer: 04/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 86 KG