MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2015-08-18 for POLIGRIP FREE manufactured by Glaxosmithkline Dungarvan Ltd..
[23984055]
Additional info included, the consumer reported that she had some skin rip off her gums and cause bleeding when she removed her dentures after she used poligrip. She also advised that she experienced a lot of pain and suffering because of this issue. The consumer also indicated that she was a first time user of this product. Follow up case was received from the consumer on (b)(4) 2015. The consumer returned 1 tube of poligrip free and provided the lot number and expiration for the product, lot v13444a and expiration october 2016. She reported that her condition was getting better since the initial report. She also indicated that she had a hospital visit and they could not do anything since the initial report. She also advised that she intended to see her denturist for an appointment on (b)(6) 2015. She reported that she saw an health care professional for her condition and indicated that she was prescribed tramadol for pain for her condition. The action taken of poligrip free was withdrawn.
Patient Sequence No: 1, Text Type: N, H10
[23984056]
Bleeding [hemorrhage]. Skin ripping off gums [gingival recession]. Pain. Suffering. Case description: this case was reported by a consumer via call center representative and described the occurrence of gingival recession in a (b)(6) female pt who received gsk denture adhesive (formulation unk) (poligrip unk) unk for product used for unk indication. Concurrent medical conditions included diabetes, caffeine consumption (1 cup of coffee a day for many years) and denture wearer. On an unk date, the pt started poligrip unk. On (b)(6) 2015, an unk time after starting poligrip unk, the pt experienced gingival recession, hemorrhage (serious criteria gsk medically significant), pain and suffering. On an unk date, the outcome of the gingival recession, hemorrhage, pain and suffering were unk. It was unk if the reporter considered the gingival recession, hemorrhage, pain and suffering to be related to poligrip unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2015-00002 |
| MDR Report Key | 5020838 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2015-08-18 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-07-21 |
| Date Added to Maude | 2015-08-21 |
| 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 277090000 |
| Manufacturer Country | US |
| Manufacturer Postal | 277090000 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POLIGRIP FREE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-08-18 |
| Lot Number | V13444A |
| Device Expiration Date | 2016-10-01 |
| Operator | LAY USER/PATIENT |
| 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, WATERFORD EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-18 |