MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT; DENTURE CLEANSER

Device Problem Device Expiration Issue (1216)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Mfr 1020379-2017-00011 is associated with argus case (b)(4), polident.

Event Description

Itchy hands / adverse reaction on her hand [itching both hands], expired product used [expired product administered], excessive scratching [scratch], become red due to excessive scratching [skin red], continues to use the product to brush her dentures despite it being expired [intentional product misuse].Case description: this case was reported by a consumer via call center representative and described the occurrence of itching both hands in a female patient who received double salt denture cleanser (polident) unknown (batch number unknown, expiry date july 2016) for denture wearer.On an unknown date, the patient started polident.On an unknown date, an unknown time after starting polident, the patient experienced itching both hands (serious criteria hospitalization), expired product administered (serious criteria hospitalization), scratch, skin red and intentional product misuse.Polident was continued with no change.On an unknown date, the outcome of the itching both hands and expired product administered were not recovered/not resolved and the outcome of the scratch, skin red and intentional product misuse were unknown.It was unknown if the reporter considered the itching both hands, expired product administered, scratch, skin red and intentional product misuse to be related to polident.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: initial and both follow-up information processed together.Initial report (b)(6) 2017: a consumer called to report that his girlfriend experienced an adverse event while using polident (variant unspecified).His girlfriend used the product while taking a shower and had an adverse reaction on her hand.When the reporter was asked about the product variant that was used, the reporter mentioned that his girlfriend had binned the product.Follow up report 23 jan 2017: the reporter is a friend of the consumer.She reported that when her friend bought the suspected product, it was expired.Her friend continues to use the product to brush her dentures despite it being expired on jul-2016.She went to see multiple doctors but her hands still feels itchy and become red due to excessive scratching.Recently yesterday ((b)(6) 2017), she was admitted to the hospital for further investigation.The reporter refused to provide further information.Follow up report: 24 jan 2017: the call centre representative supervisor observed that the caller might be a prank caller due to the following reasons: consumer sounded female but claimed to be a male.Consumer left contact details however when tried to call the number it was routed to a police station.

• Brand Name: POLIDENT
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6294006
• MDR Text Key: 66284883
• Report Number: 1020379-2017-00011
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 01/20/2017

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
• Device Operator: No Information
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 02/01/2017
• 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