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

Lot Number UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).Product quality (issue- (b)(4)) is associated with suspect product super poligrip original, not polident.

Event Description

Where it dissolved, i'm swallowing that [accidental device ingestion] if i leave them in a plastic dish overnight and the next morning clean the denture, i'm wondering is it harmful to leave my dentures in this overnight [wrong technique in device usage process].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) male patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch number m9c9, expiry date unknown) for denture wearer.This case was associated with a product complaint.Co-suspect products included denture cleanser (polident 3 minute) tablet (batch number unknown, expiry date unknown) for denture wearer.On an unknown date, the patient started super poligrip original (zinc free formula) and polident 3 minute.On an unknown date, an unknown time after starting super poligrip original (zinc free formula) and polident 3 minute, the patient experienced accidental device ingestion (serious criteria gsk medically significant), wrong technique in device usage process and product complaint.The action taken with super poligrip original (zinc free formula) was unknown.The action taken with polident 3 minute was unknown.On an unknown date, the outcome of the accidental device ingestion, wrong technique in device usage process and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to super poligrip original (zinc free formula).It was unknown if the reporter considered the wrong technique in device usage process to be related to polident 3 minute.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: adverse event information was received via live call on 26 august 2019.The consumer stated that, "denture cleanser polident.The directions here, i have been using the polident adhesive, my dentures according to the directions says 3-5 minutes? if i leave them in a plastic dish overnight and the next morning clean the denture, does that make a difference.I'm looking at the green tube super poligrip denture adhesive, the orange tube isn't as good as the green.This holds well.I'm wondering is it harmful to leave my dentures in this overnight.This doesn't hold the dentures well.It came apart well before the day was over.Super strong all day hold is misleading.Since i started using the other one, i was kind of curious, it just kind of dissolved.Where it dissolved, i'm swallowing that, does that affect my intestines somehow? sometimes i use less than what it says.The green tube is more expensive than the orange tube.Lot number m9c9 orange tube(original) green(free)." follow up information was received on 30 august 2019 from quality assurance (qa) department regarding complaint (b)(4) (issue number) for super poligrip original with lot number m9c9.The investigation report concluded that the complaint stands unsubstantiated.The complaint sample was not received at the investigation site.No sample was returned for this complaint and the batch details provided was not valid hence a full investigation could not be completed.On the basis of this the complaint could not be investigated further.Hence the complaint was considered to be unsubstantiated.

• Brand Name: POLIDENT 3 MINUTE
• 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: 9097490
• MDR Text Key: 164098903
• Report Number: 1020379-2019-00044
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 08/26/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/20/2019
• 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: 80 YR