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

Model Number LVA1028L

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Pain (1994)

Event Type  Injury  

Event 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
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): NINGBO HAISHU ZONGHAI ARTWARE CO., LTD. ; cn
• MDR Report Key: 8949647
• MDR Text Key: 156275652
• Report Number: MW5089459
• Device Sequence Number: 1
• Product Code: IKX
• UDI-Device Identifier: 00818323026221
• UDI-Public: 00818323026221
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LVA1028L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1