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U.S. Department of Health and Human Services

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

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GLAXOSMITHKLINE DUNGARVAN LTD NEW POLIGRIP SI; DENTURE ADHESIVE Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problems Urinary Retention (2119); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
Mfr report is associated with argus case (b)(4), new poligrip si.New poligrip si is marketed in the us as poligrip denture adhesive cream.
 
Event Description
Urinary retention [urinary retention].Faeces hard [faeces hard].Constipation [constipation].Device use error [device use error].Case description: this case was reported by a consumer via call center representative and described the occurrence of urinary retention in a (b)(6) male patient who received double salt dental adhesive cream (new poligrip si) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip si.In (b)(6) 2018, an unknown time after starting new poligrip si, the patient experienced urinary retention (serious criteria gsk medically significant), faeces hard, constipation and device use error.In (b)(6) 2018, the outcome of the urinary retention, faeces hard and constipation were recovered/resolved.On an unknown date, the outcome of the device use error was unknown.It was unknown if the reporter considered the urinary retention, faeces hard, constipation and device use error to be related to new poligrip si.Additional details: approximately two weeks before the report, the patient used new poligrip si two times per day, because dentures came off during the period of being adjusted at a dental clinic.Thereafter, the patient experienced severe constipation and urinary retention.The patient noted that faeces became hard due to the adhesive.Four days later, the events had resolved.Since the adjustment of the dentures was completed, the patient did not use new poligrip si as of the report.No further information is expected.
 
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Brand Name
NEW POLIGRIP SI
Type of Device
DENTURE ADHESIVE
Manufacturer (Section D)
GLAXOSMITHKLINE DUNGARVAN LTD
dungarvan, waterford
EI 
Manufacturer Contact
po box 13398
research triangle park, NC 27709
MDR Report Key8066539
MDR Text Key127062651
Report Number3003721894-2018-00404
Device Sequence Number1
Product Code KOT
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Date Manufacturer Received11/07/2018
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 Number1
Patient Outcome(s) Other;
Patient Age81 YR
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