MAUDE Adverse Event Report: GLAXOSMITHKLINE LLC POLIDENT; DENTURE CLEANSER

Lot Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146); Caustic/Chemical Burns (2549)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), polident.

Event Description

Blisters in her throat [oropharyngeal blistering].Blisters in her mouth [blistering of mouth].Swelling in her mouth [swollen mouth].Swelling in her throat [throat swelling].Burns painfully [burning oral sensation].Burns painfully [oral pain].Case description: this case was reported by a consumer and described the occurrence of oropharyngeal blistering in a female patient who received double salt denture cleanser (polident) cream (batch number unknown, expiry date unknown) for product used for unknown indication.Co-suspect products included double salt dental adhesive cream (super poligrip) unknown (batch number unknown, expiry date unknown) for drug use for unknown indication.On an unknown date, the patient started polident and super poligrip.On an unknown date, an unknown time after starting polident and super poligrip, the patient experienced oropharyngeal blistering (serious criteria gsk medically significant), blistering of mouth, swollen mouth, throat swelling, burning oral sensation and oral pain.On an unknown date, the outcome of the oropharyngeal blistering, blistering of mouth, swollen mouth, throat swelling, burning oral sensation and oral pain were recovered/resolved.It was unknown if the reporter considered the oropharyngeal blistering, blistering of mouth, swollen mouth and throat swelling to be related to polident and super poligrip.The reporter considered the burning oral sensation and oral pain to be related to polident and super poligrip.Additional information: adverse event (ae) information was reported by consumer via email on 16 august 2016.Consumer reported while wearing her dentures she got swelling and blisters in her mouth and throat, and it burns painfully.Consumer reported it went away when her dentures were out, though she did not stated that she discontinued use of the products.Consumer reported using polident, variant unspecified, and super poligrip, variant unspecified.The action taken with polident and super poligrip was unknown.Follow up was not possible.

• Brand Name: POLIDENT
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): GLAXOSMITHKLINE LLC; 3169 route 145; east durham NY 12423
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5889781
• MDR Text Key: 52549145
• Report Number: 1314819-2016-00006
• 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: 08/16/2016

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: UNKNOWN
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 08/19/2016
• 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