MAUDE Adverse Event Report: TOWER LABORATORIES LTD DG HEALTH EFFERVESCENT OVERNIGHT DENTURE CLEANSER TABLETS; EFFERVESCENT DENTURE CLEANSER TABLETS

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

Patient Problem No Code Available (3191)

Event Date 06/11/2014

Event Type  No Answer Provided  

Event Description

Consumer purchased the dg health overnight denture cleanser and after using the product, developed blisters in her mouth.

• Brand Name: DG HEALTH EFFERVESCENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: EFFERVESCENT 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: robert stone ; 8 industrial park road; centerbrook, CT 06409 ; 8607672127
• MDR Report Key: 3913884
• MDR Text Key: 21488916
• Report Number: 1219540-2014-00004
• 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: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other