MAUDE Adverse Event Report: BLOCK DRUG CO., INC COREGA TABS WHITENING; DENTURE CLEANSER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Discomfort (2330)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Mdr 1020379-2018-00069 is associated with argus case (b)(4), corega tabs whitening.Corega tabs whitening is marketed as polident denture cleaning tablets in the us.

Event Description

Accidental intake of product (accidental device ingestion).Cold sensation in stomach (stomach discomfort).Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a elderly male patient who received denture cleanser (corega tabs whitening) tablet for product used for unknown indication.On an unknown date, the patient started corega tabs whitening.On (b)(6) 2018, an unknown time after starting corega tabs whitening, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the patient experienced stomach discomfort.On an unknown date, the outcome of the accidental device ingestion and stomach discomfort were unknown.It was unknown if the reporter considered the accidental device ingestion and stomach discomfort to be related to corega tabs whitening.Additional details, the case referred to a consumer (age not specified), who on (b)(6), took a tablet of corega tabs whitening on error because he mistook it with a medication he took for his stomach and presented with cold sensation in his stomach.He tried to induce vomiting after that.

• Brand Name: COREGA TABS WHITENING
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 8127332
• MDR Text Key: 129154256
• Report Number: 1020379-2018-00069
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 11/27/2018
• 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