MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER (UNKNOWN)

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Report# 1020379-2019-00013 is associated with argus case (b)(4), polident denture cleanser (unknown).Polident denture cleanser is marketed as polident tablets in the us.

Event Description

Haemorrhage subcutaneous.Case description: this case was reported by a consumer via call center representative and described the occurrence of haemorrhage subcutaneous in a (b)(6) year-old female patient who received denture cleanser (polident denture cleanser (unknown)) tablet for denture wearer.Co-suspect products included denture cleanser (polident double power) tablet for denture wearer.Concurrent medical conditions included denture wearer and wheelchair user.On an unknown date, the patient started polident denture cleanser (unknown) (other) at an unknown dose and frequency and polident double power (other) at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser (unknown) and polident double power, the patient experienced haemorrhage subcutaneous (serious criteria gsk medically significant).The action taken with polident denture cleanser (unknown) was unknown.The action taken with polident double power was unknown.On an unknown date, the outcome of the haemorrhage subcutaneous was not recovered/not resolved.It was unknown if the reporter considered the haemorrhage subcutaneous to be related to polident denture cleanser (unknown) and polident double power.Additional details the patient was receiving antithrombotic drug.On an unknown date, the patient started to use polident denture cleanser (unknown).It was unknown when the patient started using polident denture cleanser, but the patient had been using the product since before.The patient had recently been using polident double power.Since the patient was using a wheelchair, subcutaneous haemorrhage occurred by bumping against somewhere.When the subcutaneous haemorrhage occurred was unknown.The patient was trying to determine the cause of the event.No further information is expected.

• Brand Name: POLIDENT DENTURE CLEANSER (UNKNOWN)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC
• MDR Report Key: 8382843
• MDR Text Key: 137593516
• Report Number: 1020379-2019-00013
• 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: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 02/21/2019
• 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
• Patient Age: 93 YR