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 Death (1802)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Completed suicide [completed suicide].Case description: this case was reported by a physician via sales rep and described the occurrence of completed suicide in a (b)(6)-decade-old female patient who received denture cleanser (polident denture cleanser (unknown)) unknown for an unknown indication.Concurrent medical conditions included dialysis.On an unknown date, the patient started polident denture cleanser (unknown).On an unknown date, an unknown time after starting polident denture cleanser (unknown), the patient experienced completed suicide (serious criteria death and gsk medically significant) and intentional product misuse (serious criteria death).On an unknown date, the outcome of the completed suicide and intentional product misuse were fatal.The reported cause of death was completed suicide.It was unknown if the reporter considered the completed suicide to be related to polident denture cleanser (unknown).[clinical course] present illness: receiving dialysis.The patient was taking other drugs as well (benzodiazepine [hypnotics], anticholinergic agent).On unknown date the patient drank a large amount of polident denture cleanser (unknown) for the purpose of committing suicide.Completed suicide (seriousness: fatal and gsk medically significant) developed.

Event Description

Toxicity to various agents [acute drug intoxication].Completed suicide [completed suicide].Case description: this case was reported by a physician via sales rep and described the occurrence of completed suicide in a 7-decade-old female patient who received denture cleanser (polident denture cleanser (unknown)) unknown for an unknown indication.Concurrent medical conditions included dialysis.On an unknown date, the patient started polident denture cleanser (unknown).On an unknown date, an unknown time after starting polident denture cleanser (unknown), the patient experienced completed suicide (serious criteria death and gsk medically significant) and intentional product misuse (serious criteria death).On an unknown date, the outcome of the completed suicide and intentional product misuse were fatal.The reported cause of death was completed suicide.It was unknown if the reporter considered the completed suicide to be related to polident denture cleanser (unknown).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] present illness: receiving dialysis.

Manufacturer Narrative

Argus case (b)(4).

• Brand Name: POLIDENT DENTURE CLEANSER (UNKNOWN)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis, TN
• MDR Report Key: 9133603
• MDR Text Key: 160521472
• Report Number: 1020379-2019-00047
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2019
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 57 YR
• Patient Weight: 73