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..
[25879400]
.
Patient Sequence No: 1, Text Type: N, H10
[25879401]
Intestines infection, nose congestion, possible allergic reaction, throat congestion. Case description: this case was reported by a consumer and described the occurence of ill-defined intestinal infections in a (b)(6) year old female patient who received double salt dental adhesive cream (super poligrip extra care with poliseal (zinc free formula)) cream (batch no. 9f6a, 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 ill-defined intestinal infections (serious criteria gsk medically significant), nasal congestion, allergic reaction and upper respiratory tract congestion. Super poligrip extra care with poliseal (zinc free formula) was continued with no change. On an unk date, the outcome of the ill-defined intestinal infections, nasal congestion, allergic reaction and upper respiratory tract congestion were not recovered/not resolved. The reporter considered the ill-defined intestinal infections to be possibly related to super poligrip extra care with poliseal (zinc free formula). It was unk if the reporter considered the nasal congestion, allergic reaction and upper respiratory tract congestion to be related to super poligrip extra care with poliseal (zinc free formula). Add'l info: consumer stated that "she had infection in her intestines. Could it be the poligrip because she used that every day? "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2015-00005 |
| MDR Report Key | 5057998 |
| Report Source | CONSUMER |
| Date Received | 2015-09-02 |
| Date of Report | 2015-08-21 |
| Date Mfgr Received | 2015-08-21 |
| 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 | 9F6A |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 |