MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER (UNKNOWN)

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

Patient Problem Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Pneumonia [pneumonia].Lung opacity [lung opacity].Case description: this case was reported by a consumer via call center representative and described the occurrence of pneumonia in a (b)(6)-year-old male patient who received double salt dental adhesive cream (new poligrip sg) cream for denture wearer.Co-suspect products included denture cleanser (polident denture cleanser (unknown)) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip sg and polident denture cleanser (unknown).On an unknown date, an unknown time after starting new poligrip sg and polident denture cleanser (unknown), the patient experienced pneumonia (serious criteria gsk medically significant), lung opacity and device use error.The action taken with polident denture cleanser (unknown) was unknown.On an unknown date, the outcome of the pneumonia, lung opacity and device use error were unknown.It was unknown if the reporter considered the pneumonia, lung opacity and device use error to be related to new poligrip sg.It was unknown if the reporter considered the pneumonia and lung opacity to be related to polident denture cleanser (unknown).[clinical course]: on an unknown date, the patient had been using new poligrip sg for years.He kept wearing his upper and lower dentures attached with new poligrip sg for 24 hours even during sleeping.He removed the dentures in the morning and cleaned them with polident denture cleanser.On an unknown date, with shadows in the lung(s), the patient was diagnosed with pneumonia (serious criteria gsk medically significant).On an unknown date, the lower denture did not fit the patient these days and the denture adhesive lasted only for half a day or so and completely disappeared at night.Denture adhesive applied to the upper denture also mostly disappeared before bedtime but slightly remained, so the patient did not consider it a problem.No further information is expected.

• Brand Name: POLIDENT DENTURE CLEANSER (UNKNOWN)
• 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: 10835440
• MDR Text Key: 216322833
• Report Number: 1020379-2020-00055
• 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,foreign
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2020
• 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
• Patient Age: 83 YR