MAUDE Adverse Event Report: TOWER LABORATORIES LTD. CARE ONE DENTURE CLEANSER - 3 MINUTE; BILAYER 3-MINUTE DENTURE CLEANSER TABLETS

Lot Number 8220010

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

Patient Problems Itching Sensation (1943); Respiratory Distress (2045); Seizures (2063); Alteration In Body Temperature (2682)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Care one denture cleanser does contains persulfates.There is a warning on the label identifying persulfates are in the product as well as them being a known allergen.No product was returned for evaluation.The evaluation summary attached is an analysis of retain samples from the specific lot number identified by the patient.All test results were confirmed to be within specification.

Event Description

Reporter stated patient had a severe life threatening reaction to persulfates.Patient's hands got itchy, she had a seizure, she went into respiratory arrest, had low blood pressure, and low temp.Patient was hospitalized.

• Brand Name: CARE ONE DENTURE CLEANSER - 3 MINUTE
• Type of Device: BILAYER 3-MINUTE DENTURE CLEANSER TABLETS
• Manufacturer (Section D): TOWER LABORATORIES LTD.; 8 industrial park road; centerbrook CT 06409
• Manufacturer (Section G): TOWER LABORATORIES LTD.; 8 industrial park road; centerbrook CT 06409
• Manufacturer Contact: crystal fisher ; 8 industrial park road; centerbrook, CT 06409 ; 8607672127
• MDR Report Key: 8401557
• MDR Text Key: 138207034
• Report Number: 0001219540-2019-00001
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 03/04/2019

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: 07/31/2021
• Device Lot Number: 8220010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization