MAUDE Adverse Event Report: PINGHU ASPEL TECHNOLOG CORP. FEATHERLIGHT WALKER; ROLLATOR

Model Number LR-210-FBD-BL

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 05/14/2016

Event Type  malfunction  

Event Description

When patient sat on this four wheeled walker, the front caster detached and she fell backward.There was no injury or medical attention given.

• Brand Name: FEATHERLIGHT WALKER
• Type of Device: ROLLATOR
• Manufacturer (Section D): PINGHU ASPEL TECHNOLOG CORP.; group no. 12 quingsha village; xingcang town; pinghu city, jiaxing, zhejiang 31420 5; CH 314205
• MDR Report Key: 5847505
• MDR Text Key: 51177358
• Report Number: 1056127-2016-00007
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756916602
• UDI-Public: 754756916602
• 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: 08/04/2016,07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LR-210-FBD-BL
• Device Catalogue Number: W1660B
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2016
• Distributor Facility Aware Date: 07/18/2016
• Device Age: 8 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 74