MAUDE Adverse Event Report: GLAXOSMITHKLINE SUPER PLOIGRIP FREE DENTURE ADHESIVE CREAM; DOUBLE SALT DENTAL ADHESIVE CREAM

Lot Number P14104A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Type  Other  

Event Description

This case was reported by a consumer and described the occurrence of renal injury in a (b)(6) old male pt who received double salt dental adhesive cream (super poligirp free denture adhesive cream) for denture adhesion.A physician or other healthcare professional has not verified this report.On an unk date, the pt started double salt dental adhesive cream.At an unk time after starting double salt dental adhesive cream, the pt experienced renal injury.This case was assessed as medically serious by gsk.Treatment with double salt dental adhesive cream was continued.At the time of reporting, the event was unresolved.Consumer reported that he has used super poligrip free for a long time.Consumer stated that (b)(6) 2014 his doctor told him he has chronic kidney damage.Consumer is still experiencing this event and is continuing to use the product.Customer reported that he had an ultrasound on (b)(6) 2014.The pt did not provide contact info as he did not wish to be contacted; therefore, this case is lost to follow-up.

Manufacturer Narrative

The mfr's report number for this case is 9681138-2014-00019.Super poligrip is manufactured in (b)(4).The lot number for this product is available; however, it is unk whether the product will be returned for quality assurance testing.(b)(4).

• Brand Name: SUPER PLOIGRIP FREE DENTURE ADHESIVE CREAM
• Type of Device: DOUBLE SALT DENTAL ADHESIVE CREAM
• Manufacturer (Section D): GLAXOSMITHKLINE; rtp NC 27709
• Manufacturer (Section G): GLAXOSMITHKLINE; ireland, clocherane; youghal rd; dungarvan ; EI
• Manufacturer Contact: po box 13398; rtp, NC 27709 ; 8888255249
• MDR Report Key: 4073009
• MDR Text Key: 4825409
• Report Number: 9681138-2014-00019
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: P14104A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2014
• 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
• Treatment: LUTEIN; ZINC; GARLIC
• Patient Outcome(s): Other
• Patient Age: 69 YR