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

Lot Number S89Y

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), corega bio cleanser.Corega bio cleanser is marketed as polident denture cleansing tablets in the us.

Event Description

Product swallowed by mistake [accidental device ingestion] 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 bio cleanser) tablet (batch number s89y, expiry date 30th september 2020) for dental cleaning.On an unknown date, the patient started corega bio cleanser.On an unknown date, an unknown time after starting corega bio cleanser, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with corega bio cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion was not reported.It was unknown if the reporter considered the accidental device ingestion to be related to corega bio cleanser.Additional details, the case concerns a women who swallowed the product by mistake.The reporter explained that by mistake she drank the glass containing the product where his son was cleaning his dental appliance with corega.She went to toxicology department and could not tell her anything else besides the fact that the product was irritative.She wanted to know if she should took something or if the this could had any side effect.

• Brand Name: COREGA BIO CLEANSER
• 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: 7765483
• MDR Text Key: 116527961
• Report Number: 1020379-2018-00042
• 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: 07/27/2018

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
• Device Expiration Date: 09/30/2020
• Device Lot Number: S89Y
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/08/2018
• 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: 50 YR