MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD DRIVE DEVILBISS; WALKER MECHANICAL

Model Number 10220-1

Device Problems Collapse (1099); Detachment Of Device Component (1104)

Patient Problems Fall (1848); Fracture, Arm (2351)

Event Date 08/15/2017

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a walker.End-user was in the bathroom when she got up and grabbed hold of the walker.The walker collapsed outward on the right side.The end user fell onto the flat walker.The rivet reportedly fell out.There was no visible damage to the walker.End-user was taken by emt to the er.End user broke the humorous bone in her right arm.As per last conversation with the spouse, the bone is still aligned so they could avoid surgery.

• Brand Name: DRIVE DEVILBISS
• Type of Device: WALKER MECHANICAL
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD; no.96, zhaoyi rd.; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 6877058
• MDR Text Key: 86699465
• Report Number: 2438477-2017-00077
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 09/19/2017,08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10220-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2017
• Distributor Facility Aware Date: 08/22/2017
• Device Age: 4 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2017
• 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: 70 YR
• Patient Weight: 176