MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-09-15 for NEW POLIGRIP SA manufactured by Glaxosmithkline Dungarvan Ltd.
[26963109]
Case comment: the dermatologist who examined the patient explained him that the adverse events were unrelated to new poligrip sa. The dentist also stated that it may have been the patient's imagination that the symptoms developed associated with the use of new poligrip sa.
Patient Sequence No: 1, Text Type: N, H10
[26963110]
Skin swelling [skin swelling of]; ill-defined disorder [skin erosion]; urticaria [blister]. Case description: this case was reported by a dentist via sales rep and described the occurrence of skin swelling in a (b)(6) year old male patient who received double salt dental adhesive cream ( new poligrip sa) cream for dentures wearer. Concurrent medical conditions included skin fragility. On (b)(6) 2014, the patient started new poligrip sa. On (b)(6) 2014, 1 day after starting new poligrip sa, the patient experienced skin swelling (serious criteria clinically significant/intervention required), skin erosion (serious criteria clinically significant/intervention required) and blister (serious criteria clinically significant/intervention required). On (b)(6) 2014, the outcome of the skin swelling, skin erosion and blister were recovered/resolved. The reporter considered the skin swelling, skin erosions and blister to be unrelated to new poligrip sa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2015-00009 |
| MDR Report Key | 5108097 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-09-15 |
| Date of Report | 2014-11-06 |
| Date of Event | 2014-07-15 |
| Date Mfgr Received | 2014-11-06 |
| Date Added to Maude | 2015-09-28 |
| 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 | NEW POLIGRIP SA |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-09-15 |
| Device Availability | * |
| Device Age | DA |
| 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. Required No Informationntervention | 2015-09-15 |