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

Lot Number 58103XC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Her stomach feels crampy [stomach cramps].If you ingest it [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a (b)(6) year-old female patient who received denture cleanser (polident denture cleanser tablets) tablet (batch number 58103xc, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets.On (b)(6) 2021, an unknown time after starting polident denture cleanser tablets, the patient experienced stomach cramps and accidental device ingestion (serious criteria gsk medically significant).The action taken with polident denture cleanser tablets was unknown.On an unknown date, the outcome of the stomach cramps and accidental device ingestion were unknown.It was unknown if the reporter considered the stomach cramps and accidental device ingestion to be related to polident denture cleanser tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received via call center representative on 14-jul-2021.Consumer reported that "polident want to know what happens if you ingest it her stomach feels crampy lot 58103xc.".

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 12245296
• MDR Text Key: 264058590
• Report Number: 1020379-2021-00038
• 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
• Type of Report: Initial
• Report Date: 07/14/2021

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: Lay User/Patient
• Device Lot Number: 58103XC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 07/29/2021
• 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: 54 YR