MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIGRIP ULTRA; DENTURE ADHESIVE

Device Problems Loss of or Failure to Bond (1068); Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Fall (1848); Hemorrhage/Bleeding (1888); Neurological Deficit/Dysfunction (1982); Overdose (1988); Dizziness (2194); Therapeutic Response, Decreased (2271); Toxicity (2333); Malaise (2359); Ambulation Difficulties (2544)

Event Date 01/01/2015

Event Type  Other  

Event Description

Zinc poisoning [metal poisoning]; sensation in her leg [abnormal sensation of limbs]; head spinning [head spinning]; loss of balance [balance difficulty]; fall; stomach pain; looked pale; bleeding lips [lip hemorrhage]; ill [unwell]; excessive use of product [overdose]; lack of effect [ lack of drug effect].Case description: this case was reported by a consumer via call center representative and described the occurrence of metal poisoning in a (b)(6) year old female patient who received gsk denture adhesive (formulation unknown) (poligrip ultra) unknown for denture wearer.Concurrent medical conditions included deafness.On an unknown date, the patient started poligrip ultra.In 2015, an unknown time after starting poligrip ultra, the patient experienced metal poisoning (serious criteria gsk medically significant), abnormal sensation of limbs, head spinning, balance difficulty, fall, stomach pain, looked pale, lip hemorrhage, unwell, overdose and lack of drug effect.On an unknown date, the outcome of the metal poisoning, abnormal sensation of limbs, head spinning, balance difficulty and fall were not recovered/not resolved and the outcome of the stomach pain, looked pale, lip hemorrhage and unwell were recovered/resolved and the outcome of the overdose and lack of drug effect were not reported.It was unknown if the reporter considered the metal poisoning, abnormal sensation of limbs, head spinning, balance difficulty, fall, stomach pain, looked pale, lip hemorrhage, unwell, overdose and lack of drug effect to be related to poligrip ultra.Additional details: a call was received from a consumer regarding her mother who has been using poligrip ultra for over 20 years.The daughter reported that her mother had received new dentures approximately three months ago which failed to hold, her mother; therefore, applied more of the product to keep them in place.Subsequent to this she started to complain of stomach pains, "head spinning", sensation in leg, and loss of balance.She also felt ill and suffered a fall.The mother was diagnosed with zinc poisoning by her gp.At the time of reporting the events were unresolved.

• Brand Name: POLIGRIP ULTRA
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5108100
• MDR Text Key: 26965840
• Report Number: 3003721894-2015-00008
• 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,foreign
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 09/04/2015
• 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: 75 YR