MAUDE Adverse Event Report: SCHERING CORP. CUSHION GRIP; DENTURE ADHESIVE

Device Problem Insufficient Information (3190)

Patient Problem Cancer (3262)

Event Type  Injury  

Event Description

Event verbatim: cancer.Case description: this spontaneous reported originating from the united states as rec'd from a consumer's wife refers to a male pt of unk age.This reported concerns one pt and one device.This pt used the 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 was diagnosed with cancer (medically significant).No treatment info was reported.The action taken and the outcome were unk.The reporter considered the pt being diagnosed with cancer to be not related to the polyvinyl acetate (cushion grip).The polyvinyl acetate (cushion grip) was not available for investigation.For the polyvinyl acetate (cushion grip), the lot number was not available and the serial number was available.Add'l info was not expected.

Manufacturer Narrative

(b)(4).

• Brand Name: CUSHION GRIP
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): SCHERING CORP.; 2000 galloping hill rd.; kenilworth NJ 07033 053
• Manufacturer (Section G): MSD CONSUMER CARE INC; 4207 michigan avenue rd ne; cleveland TN 37323
• MDR Report Key: 4605172
• MDR Text Key: 5464270
• Report Number: 2210048-2015-00002
• 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: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• 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: 03/06/2015
• 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): Other