MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04,consumer,foreign,oth report with the FDA on 2015-06-30 for POLIGRIP STRONG HOLD DENTURE ADHESIVE CREAM manufactured by Glaxosmithkline Dungarvan Ltd..
[6048256]
Choking up/worsening of choking up [choking] mouth numbness/ worsening of mouth numbness [numbness oral] not feeling well /worsening of not feeling well [feeling unwell] difficulty talking [speech disorder]. Condition aggravated [condition aggravated]. Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a female pt who received double salt dental adhesive cream (poligrip strong hold denture adhesive cream) unk for product used for unk indication. Concurrent medical conditions included denture wearer. On an unk date, the pt started poligrip strong hold denture adhesive cream. On (b)(6) 2015, an unk time after starting poligrip strong hold denture adhesive cream, the pt experienced choking (serious criteria gsk medically significant), numbness oral, feeling unwell and speech disorder. On an unk date, the pt experienced condition aggravated. On an unk date, the outcome of the choking, numbness oral, feeling unwell, speech disorder and condition aggravated were unk. It was unk if the reporter considered the choking, numbness oral, feeling unwell, speech disorder and condition aggravated to be related to poligrip strong hold denture adhesive cream. Additional info: the consumer reported that she used poligrip strong hold for the first time and noticed that her mouth became numb after she removed her dentures from her mouth. She stated that she had worn her dentures for approximately one hour when she noticed that her mouth was numb. She advised that she was still experiencing the numbness at the time of the report and was choking up during the report. She indicated that she was not feeling well and that her symptoms were getting worse. The report was not completed because the consumer had difficulty talking as she was choking, so she had her husband complete the report. Her husband advised that he would bring the consumer to see an hcp. The action taken was unk.
Patient Sequence No: 1, Text Type: D, B5
[69471442]
Follow up was received from the consumer on 09 september 2015. The consumer returned one tube of poligrip strong hold and provided the lot number (uh3b) and expiration date (october 2017) for the product. She did not indicate whether her condition had subsided or whether she had taken any further actions since the initial report. She reported that she saw a health care professional for treatment and was not prescribed any medication for her condition. Action taken for the poligrip strong hold denture adhesive cream was unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681138-2015-00036 |
| MDR Report Key | 4881509 |
| Report Source | 00,01,04,CONSUMER,FOREIGN,OTH |
| Date Received | 2015-06-30 |
| Date of Report | 2015-06-23 |
| Date of Event | 2015-06-23 |
| Date Mfgr Received | 2015-06-23 |
| Date Added to Maude | 2015-07-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP STRONG HOLD DENTURE ADHESIVE CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-06-30 |
| Lot Number | UH3B |
| Device Expiration Date | 2017-10-01 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE DUNGARVAN LTD. |
| Manufacturer Address | DUNGARVAN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-30 |