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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE; DENTURE CLEANSER

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BLOCK DRUG CO., INC. POLIDENT 3 MINUTE; DENTURE CLEANSER Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Chemical Exposure (2570); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Mfr 1020379-2017-00062 is associated with argus case (b)(4), polident denture cleanser tablets.
 
Event Description
I drank the polident [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and accidental ingestion of drug.On an unknown date, the outcome of the accidental device ingestion and accidental ingestion of drug were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident denture cleanser tablets.Additional details, adverse event information was received on 02 august 2017.The consumer stated, "i thought i was fixing alka-seltzer or i thought it was but it instead was the polident and i drank the polident".
 
Manufacturer Narrative
1020379-2017-00062 is associated with argus case (b)(4), polident denture cleanser tablets.Follow-up information received on 14 september 2017.The report confirmed that the suspect product was polident 3 minute tablets (initially reported as polident denture cleanser tablets).
 
Event Description
Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and accidental ingestion of drug.On an unknown date, the outcome of the accidental device ingestion and accidental ingestion of drug were unknown.It was unknown if the reporter considered the 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 on 02 august 2017.The consumer stated, "i thought i was fixing alka-seltzer or i thought it was but it instead was the polident and i drank the polident".Follow up information was received on 14 september 2017.The consumer stated it was the polident 3 minute.Poison control cleared her and stated that she did not need to go to the doctors.No lot number was provided as those were the last of the tablets she had at the time.The suspect product was updated from "polident denture cleanser tablets" to "polident 3 minute".
 
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Brand Name
POLIDENT 3 MINUTE
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 Key6776436
MDR Text Key82150319
Report Number1020379-2017-00062
Device Sequence Number1
Product Code EFT
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/02/2017
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 Lay User/Patient
Initial Date Manufacturer Received 08/02/2017
Initial Date FDA Received08/09/2017
Supplement Dates Manufacturer Received09/14/2017
Supplement Dates FDA Received09/21/2017
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 Number1
Patient Outcome(s) Other;
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