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

Lot Number MA031814E

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Injury (2348)

Event Date 08/11/2018

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4) polident 3 minute.

Event Description

Allergic reaction to polident [allergic reaction].I had been getting swollen lips [lip swelling].I had been getting sore lips [lip soreness].Case description: this case was reported by a consumer via regulatory authority and described the occurrence of injury in a patient who received denture cleanser (polident 3 minute) tablet (batch number ma031814e, expiry date unknown) for oral hygiene.Concomitant products included melatonin.In 2018, the patient started polident 3 minute.On (b)(6) 2018, an unknown time after starting polident 3 minute, the patient experienced injury (serious criteria other: serious by fda), allergic reaction, lip swelling and lip soreness.Polident 3 minute was discontinued in 2018 (dechallenge was unknown).On an unknown date, the outcome of the injury, allergic reaction, lip swelling and lip soreness were unknown.The reporter considered the injury, allergic reaction, lip swelling and lip soreness to be related to polident 3 minute.Additional information: adverse event information was received via regulator authority (fda) on 27 august 2018.Consumer reported serious injury including, "continued and worsening allergic reaction to polident.I used it to clean retainers as was suggested by dentist.I had been getting swollen and sore lips in reaction to it.The product was over the counter product".The fda ctu id number reported as mw5079154.This report is being resubmitted to capture corrections.The information was received on 27 august 2018.The event injury was removed and other events allergic reaction, lip swelling and lip soreness was marked as serious (serious as per fda).

• 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: 7846586
• MDR Text Key: 119326658
• Report Number: 1020379-2018-00055
• 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
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: MA031814E
• Date Manufacturer Received: 08/27/2018
• 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