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

Lot Number MG051524B

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Collapse (2416); Respiratory Tract Infection (2420)

Event Type  Injury  

Event Description

Lungs collapsed [collapse of lung].Cough [cough].Mucus unspecified [ill-defined disorder].This case was reported by a consumer and described the occurrence of collapse of lung in a female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number (b)(4) , expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced collapse of lung (serious criteria (b)(4) medically significant), cough and ill-defined disorder.Polident denture cleanser tablets was continued with no change.On an unknown date, the outcome of the collapse of lung was unknown and the outcome of the cough and ill-defined disorder were not recovered/not resolved.The reporter considered the collapse of lung, cough and ill-defined disorder to be related to polident denture cleanser tablets.This report is made by (b)(4) without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information, the adverse event information received on (b)(4) 2015.The consumer called to report that the chemicals that polident 3 minute was made of have caused her to have a cough, mucus, and collapsed lungs.The consumer reported her age as close to 60.

• 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: 5254304
• MDR Text Key: 32299916
• Report Number: 1020379-2015-00016
• 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: 11/03/2015

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: MG051524B
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/30/2015
• 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