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

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

"i swallowed a little bit of polident daily cleanser for retainers by accident [accidental device ingestion]." case description: this case was reported by a consumer via call center representative, and described the occurrence of accidental device ingestion in a patient who received denture cleanser (polident retainer cleanser) unknown (batch number unk, expiry date unknown) for oral hygiene.On (b)(6) 2020, the patient started polident retainer cleanser.On (b)(6) 2020, an unknown time after starting polident retainer cleanser, the patient experienced accidental device ingestion (serious criteria gsk medically significant).Polident retainer cleanser was discontinued on (b)(6) 2020 (de-challenge was positive).On (b)(6) 2020, the outcome of the accidental device ingestion was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion to be related to polident retainer cleanser.Additional details: the patient was using polident daily cleanser for retainers, and they wallowed a little bit of it by accident.They spited it out but might have swallowed a small quantity.They queried if they should drink a lot of water, and stated they felt very well.

• Brand Name: POLIDENT RETAINER CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 10822030
• MDR Text Key: 215904627
• Report Number: 1020379-2020-00057
• 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,foreign
• Type of Report: Initial
• Report Date: 10/29/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/11/2020
• 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