MAUDE Adverse Event Report: NINGBO HAISHU ZONGHAI ARTWARE CO., LTD. VIVE SUCTION GRAB BAR; AID, TRANSFER

Model Number	LVA1028L
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer left a comment stating, "worse product i ever bought it stuck after showering i grab the handle and it came off, i hurt myself." fda safety report id# (b)(4).

• Brand Name: VIVE SUCTION GRAB BAR
• Common Device Name: AID, TRANSFER
• Manufacturer (Section D): NINGBO HAISHU ZONGHAI ARTWARE CO., LTD. ; cn
• MDR Report Key: 8949647
• Report Number: MW5089459
• Device Sequence Number: 2585127
• Product Code: IKX
• UDI-Device Identifier: 00818323026221
• UDI-Public: 00818323026221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: LVA1028L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1