MAUDE Adverse Event Report: TOWER LABORATORIES, LTD. CARE DONE DENTURE CLEANER; CLEANSER, DENTURE, OVER THE COUNTER

Lot Number 8220010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Seizures (2063); Alteration In Body Temperature (2682)

Event Date 01/11/2019

Event Type  Injury  

Event Description

My mother used care done denture cleaner which includes persulfate.She had a severe life threatening allergic reaction to the persulfate.Her hands got itchy, she had a seizure, she went into respiratory arrest, had low blood pressure, low temp.Has been hospitalized ever since.This item was purchased at (b)(6) in (b)(6).Frequency: at bed time; how was it taken or used? cleaning partial; date the person first started taking or using the product: (b)(6) 2019, date the person stopped taking or using the product: (b)(6) 2019, why was the person using the product? cleaning partials.

• Brand Name: CARE DONE DENTURE CLEANER
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): TOWER LABORATORIES, LTD.
• MDR Report Key: 8253693
• MDR Text Key: 133711003
• Report Number: MW5083167
• Device Sequence Number: 0
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: 8220010
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 64 YR
• Patient Weight: 63