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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Diarrhea (1811); Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), corega tabs.Corega tabs are marketed as polident in the us.

Event Description

Accidental ingestion [accidental device ingestion].Severe diarrhea [diarrhea].Fecal occult blood [fecal occult blood].Increased c-reactive protein [c-reactive protein increased].Leukogram exam alteration [wbc abnormal].Nephrological alteration [renal disorder].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6) female patient who received denture cleanser (corega tabs) tablet for drug use for unknown indication.On an unknown date, the patient started corega tabs.On an unknown date, an unknown time after starting corega tabs, the patient experienced accidental device ingestion (serious criteria gsk medically significant), diarrhea, fecal occult blood, c-reactive protein increased, wbc abnormal and renal disorder.On an unknown date, the outcome of the accidental device ingestion was recovered/resolved and the outcome of the diarrhea, fecal occult blood, c-reactive protein increased, wbc abnormal and renal disorder were not reported.It was unknown if the reporter considered the accidental device ingestion to be related to corega tabs.The reporter considered the diarrhea, fecal occult blood, c-reactive protein increased, wbc abnormal and renal disorder to be related to corega tabs.Additional information: patient's daughter reported that her mother (81 years) had confounded corega tabs with an antacid drug, and due to that has accidentally ingested the suspect product.Reporter informed that after the wrongly administration of the corega tabs, patient experienced a severe and persistent diarrhea.Reporter informed that patient did a blood exam, and the results showed that she was with fecal occult blood, c-reactive protein was 15 times upper than normal value, and also revealed a lot of alteration in the leukogram exam, and also nephrological alterations.Reporter informed that 23 days ago patient has make routine exams, and that these alterations happened after the accidental ingestion of the corega tabs.Batch number and expiry date were unknown to the reporter.

• Brand Name: COREGA TABS
• 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: 7251315
• MDR Text Key: 99351990
• Report Number: 1020379-2018-00010
• 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: 01/31/2018

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
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/08/2018
• 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
• Patient Age: 81 YR