MAUDE Adverse Event Report: MSD CONSUMER CARE INC CUSHION GRIP; DENTURE ADHESIVE

Device Problem Insufficient Information (3190)

Patient Problem Congestive Heart Failure (1783)

Event Type  Injury  

Event Description

This spontaneous report originating from the united states as received from a consumer's daughter refers to a female pt of unk age.This report concerns 1 pt and 1 device.On an unk date, the pt started therapy with polyvinyl acetate (cushion grip) for an unk indication.No other co-suspects were reported.No concomitant medications were reported.On an unk date the pt experienced congestive heart failure and was in the hosp.No treatment info was reported.The action taken on the product was unk.The outcome of the event was unk.The pt's congestive heart failure was considered to be unk to the polyvinyl acetate (cushion grip).The polyvinyl acetate (cushion grip) was not available for the investigation.For the polyvinyl acetate (cushion grip), the lot number was not available and the serial number was not available.Additional info was not expected.

Manufacturer Narrative

(b)(4).

• Brand Name: CUSHION GRIP
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section G): MSD CONSUMER CARE INC; 4207 michigan ave rd ne; cleveland TN 37323
• Manufacturer Contact: po box 4; west point, PA 19486-0004 ; 2156527905
• MDR Report Key: 4589037
• MDR Text Key: 5483990
• Report Number: 2210048-2015-00001
• Device Sequence Number: 1
• Product Code: KOP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other