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

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Unknown cause of death [death].Case description: this case was reported by a consumer via call center representative and described the occurrence of death in a female patient who received double salt dental adhesive cream (ultra corega crema sin sabor) cream for product used for unknown indication.Co-suspect products included denture cleanser (corega tablets) tablet for product used for unknown indication.On an unknown date, the patient started ultra corega crema sin sabor at an unknown dose and frequency and corega tablets at an unknown dose and frequency.On an unknown date, an unknown time after starting ultra corega crema sin sabor and corega tablets, the patient experienced death (serious criteria death and gsk medically significant).On an unknown date, the outcome of the death was fatal.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the death to be related to ultra corega crema sin sabor and corega tablets.It was reported that the patient died about a year and a half ago.The patient two tubes and two bars of like effervescent tablets and trusted the product 100%.

• Brand Name: COREGA TABLETS
• 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: 9906721
• MDR Text Key: 185816882
• Report Number: 1020379-2019-00045
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 08/30/2019
• 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): Death; Other