MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-02 for SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC FREE FORMULA) manufactured by Glaxosmithkline Dungarvan Ltd..
[25615183]
Patient Sequence No: 1, Text Type: N, H10
[25615184]
Chemical burn on tongue, odd feeling on tongue / odd sensation on tongue, swollen tongue, tongue white. Case description: this case was reported by a consumer and described the occurence of chemical burn or oral cavity in a (b)(6) male patient who received double salt dental adhesive cream (super poligrip extra care with poliseal (zinc free formula)) unk (batch no. 9f6b, expiry date unk) for product used for unk indication. On an unk date, the patient started super poligrip extra care with poliseal (zinc free formula). On an unk date, an unk time after starting super poligrip extra care with poliseal (zinc free formula), the patient experienced chemical burn of oral cavity (serious criteria gsk medically significant and other: serious adverse event), tongue abnormal feeling of, swollen tongue and tongue white were not recovered/not resolved. It was unk if the reporter considered the chemical burn of oral cavity, tongue abnormal feeling of, swollen tongue and tongue white to be related to super poligrip extra care with poliseal (zinc free formula). Add'l info: adverse event (ae) information was received on 27 august 2015. Consumer reported adverse event of strange feeling on tongue further described as his tongue felt like acid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2015-00006 |
| MDR Report Key | 5058000 |
| Report Source | CONSUMER |
| Date Received | 2015-09-02 |
| Date of Report | 2015-08-27 |
| Date Mfgr Received | 2015-08-27 |
| Date Added to Maude | 2015-09-04 |
| 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 | 0 |
| Brand Name | SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC FREE FORMULA) |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-09-02 |
| Lot Number | 9F6B |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE DUNGARVAN LTD. |
| Manufacturer Address | DUNGARVAN, WATERFORD EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-02 |