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

Lot Number MK101613A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Fainting (1847); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Dizziness (2194); Pressure Sores (2326)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

The report # 1020379-2017-00029 is associated with (b)(4), polident denture cleanser tablets.

Event Description

Felt like she was going to passout [passed out]; burning sensation in her gums [burning gum]; itchiness [pruritus]; getting worse the itching and burning sensation [condition aggravated]; red spots [erythromacular rash]; red irritated red spot in the back of her jaw [irritation gum]; cold sore around the gums [cold sores]; she just felt dizzy [dizziness]; blood pressure drop.[low blood pressure].Case description: this case was reported by a consumer and described the occurrence of passed out in a female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number mk101613a, expiry date unknown) for product used for unknown indication.On (b)(6) 2017, the patient started polident denture cleanser tablets at an unknown dose and frequency.On (b)(6) 2017, 1 days after starting polident denture cleanser tablets, the patient experienced burning gum and pruritus.On (b)(6) 2017, the patient experienced condition aggravated and irritation gum.On (b)(6) 2017, the patient experienced passed out (serious criteria gsk medically significant), dizziness and low blood pressure.On an unknown date, the patient experienced erythromacular rash and cold sores.Polident denture cleanser tablets was continued with no change.On an unknown date, the outcome of the passed out, irritation gum and dizziness were unknown and the outcome of the burning gum, pruritus, condition aggravated, erythromacular rash, cold sores and low blood pressure were not recovered/not resolved.It was unknown if the reporter considered the passed out, burning gum, pruritus, condition aggravated, erythromacular rash, irritation gum, cold sores, dizziness and low blood pressure to be related to polident denture cleanser tablets.Additional information: adverse event information was received on 17 march 2017.Polident 3 minute 120ct.Lot code mk101613a.She started using it (b)(6) 2017 evening.On (b)(6) 2017 she had experienced burning sensation in her gums.On (b)(6) 2017 was started getting worse the itching and burning sensation.She saw red irritated red spot in the back of her jaw.She went to the doctor and they said it could have been a cold sore around the gums.They prescribed her oral medication for a cold sore.She took it for 2 days and the burning sensation stopped.She did not stop using the polident.On (b)(6) 2017 was when she experienced her blood pressure drop.She did not have a history of low blood pressure.She didn't check her blood pressure on (b)(6) 2017.She just felt dizzy and felt like she was going to passout.On (b)(6) 2017.She checked her blood pressure and it was 80/52.It was just going it up and down.Her dentist told her to get denture cleanser for her mouth guard.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6425478
• MDR Text Key: 70624789
• Report Number: 1020379-2017-00029
• 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: 03/17/2017

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 Lot Number: MK101613A
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 03/22/2017
• 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