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

Model Number 10400-1

Device Problem Disassembly (1168)

Patient Problem Injury (2348)

Event Date 09/15/2015

Event Type  Injury  

Event Description

Drive medical received a notice from a provider regarding an incident which involves the crutch that drive medical imports and distributes.As the enduser was coming out of the house, the hand grips on both sides of the crutches gave out causing her to fall on her butt and hit her head and the left side of her shoulder on a concrete surface.This report is based on information provided by the enduser and the provider.

• Brand Name: DRIVE MEDICAL
• Type of Device: CRUTCH
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; 98 zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 5221348
• MDR Text Key: 31073616
• Report Number: 2438477-2015-00029
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/12/2015,09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10400-1
• Device Catalogue Number: 10400-1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2015
• Distributor Facility Aware Date: 10/13/2015
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 11/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 95