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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Diarrhea (1811)

Event Type  Other  

Event Description

Accidental exposure to product, diarrhoea, haematochezia.Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental ingestion of product in a (b)(6) male patient who received double salt denture cleanser (polident denture cleanser (unk) tablet for denture wearer.Concurrent medical conditions included denture wearer, concomitant products included unk drug.On an unk date, the patient started polident denture cleanser (unk).On (b)(6) 2015, an unk time after starting polident denture cleanser (unk), the patient experienced accidental ingestion of product.On an unk date, the patient experienced diarrhoea and faeces bloodstained (serious criteria gsk medically significant).On an unk date, the outcome of the accidental ingestion of product was unk and the outcome of the diarrhoea and faeces bloodstained were recovering/resolving.It was not reported if the reporter considered the diarrhoea and faeces bloodstained to be related to polident denture cleanser (unk).Then, 2 to 3 hours after accidental ingestion of product occurred, watery diarrhoea (seriousness: non-serious) and bloodstained faeces (seriousness: gsk medically significant) developed.

• Brand Name: POLIDENT DENTURE CLEANSER (UNK)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5113743
• MDR Text Key: 27316161
• Report Number: 1020379-2015-00014
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Report Date: 09/11/2015

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• 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
• Patient Age: 71 YR