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

Lot Number 9X9P

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/27/2019

Event Type  Injury  

Manufacturer Narrative

Mdr 1020379-2019-00005 is associated with argus case (b)(4), polident overnight denture cleanser tablets.

Event Description

My husband put one in his mouth.(accidental device ingestion).The tablet was stuck.(medication stuck in throat) he did brake the tablet open so it must be a piece stuck.(device use error).Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) year-old male patient who received denture cleanser (polident overnight denture cleanser tablets) tablet (batch number 9x9p, expiry date: 31st july 2021) for dental care.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 accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the patient experienced medication stuck in throat and device use error.On an unknown date, the outcome of the accidental device ingestion, medication stuck in throat and device use error were unknown.It was unknown if the reporter considered the accidental device ingestion and device use error to be related to polident overnight denture cleanser tablets.The reporter considered the medication stuck in throat to be related to polident overnight denture cleanser tablets.Adverse event information was received on (b)(6) 2019, via phone call.Consumer reported that, "i'm calling about polident.My husband put one in his mouth.He's (b)(6) years old.He took a tablet.We've been using the polident.The box doesn't say if its dangerous.The tablet was stuck.Did call poison control and they asked if he had any reactions.He didn't have any reactions just that it was stuck.He is ok physically but it won't dissolve.I was wondering if there is something we could do to make it dissolve.Why is it not labeled in the package caution.I've never read the box because i've never had this problem before.Waiting to eat maybe if he drinks something hot it will dissolve.The tablet is stuck in his esophagus.He did brake the tablet open so it must be a piece stuck.My husband just put a tablet in a container and it dissolved immediately.The tablet is blue on one side and white on the other.I suggest that a label is put, maybe they should know but i don't know why he did this.

• 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: 8296929
• MDR Text Key: 134748203
• Report Number: 1020379-2019-00005
• 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: 01/28/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Lot Number: 9X9P
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/01/2019
• 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