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

Lot Number MJ221524B

Device Problems Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

1020379-2019-00004 is associated with argus case (b)(4), polident overnight denture cleanser tablets.

Event Description

My sister took her plate out of the solution but did not rinse off the solution.She feels that it's closing up her throat [accidental device ingestion].She feels that it's closing up her throat, but she is having throat problems anyway [throat constriction].It was expired [expired device used].My sister took her plate out of the solution but did not rinse off the solution [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)-year-old female patient who received denture cleanser (polident overnight denture cleanser tablets) tablet (batch number mj221524b, expiry date 31st october 2018) for product used for unknown indication.On an unknown date, the patient started polident overnight denture cleanser tablets.On (b)(6) 2019, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced throat constriction, expired device used and wrong technique in device usage process.On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with polident overnight denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion, expired device used and wrong technique in device usage process were unknown and the outcome of the throat constriction was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion, expired device used and wrong technique in device usage process to be related to polident overnight denture cleanser tablets.The reporter considered the throat constriction to be related to polident overnight denture cleanser tablets.Additional information: adverse event information was received via email on (b)(6) 2019.The consumer reported that, "the polident package says if swallowed, you could have allergic reactions.Do they mean swallow the actual tablet or the solution that it is in? my sister took her plate out of the solution but did not rinse off the solution.She feels that it's closing up her throat, but she is having throat problems anyway.This was a sample from her dentist.It was expired.".

• Brand Name: POLIDENT OVERNIGHT 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: 8289664
• MDR Text Key: 134594278
• Report Number: 1020379-2019-00004
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Lot Number: MJ221524B
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 01/30/2019
• 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: 89 YR