MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-04-07 for POLIGRIP ULTRA manufactured by Gsk Dungarvan Stafford Miller.
[19602433]
Weak bladder (atonic urinary bladder), dizzy periods (dizziness), stomach pains, severe and painful diarrhoea (diarrhea), cramps, discomfort in digestion (digestion impaired), discomfort in bowels (bowel discomfort), product complaint, chronic flatulence, overuse of product (extra dose administered). Case description: this case was reported by a consumer and described the occurrence of dizziness in a male patient who received gsk denture adhesive (formulation unknown) (poligrip ultra) unknown for product used for unknown indication. In 2015, the patient started poligrip ultra. In 2015, an unknown time after starting poligrip ultra, the patient experienced dizziness, stomach pain, diarrhea, cramp, digestion impaired and bowel discomfort. On an unknown date, the outcome of the dizziness, stomach pain, diarrhea and cramp were recovering/resolving and the outcome of the digestion impaired and bowel discomfort were not recovered/not resolved. It was unknown if the reporter considered the dizziness, stomach pain, diarrhea, cramp, digestion impaired and bowel discomfort to be related to poligrip ultra.
Patient Sequence No: 1, Text Type: D, B5
[20137577]
Additional details: the consumer reported that they had purchased the product a few weeks prior to reporting. After they used it they noticed a small hard lump in the base of the tube and assumed it had squashed or kinked in some way. Days later, the patient experienced dizzy periods and stomach pains. Followed by severe and painful diarrhea and cramps. The consumer reported the symptoms were disappearing slowly, but they still had "discomfort indigestion and bowels. " follow up received 19 march 2015: concurrent conditions included arthritis. Concomitant medication included ibuprofen. The patient used poligrip ultra once or twice daily as dental fixative from (b)(6) 2015. The patient used the product on half denture plate fix, top and bottom. The events started in (b)(6) 2015. The patient experienced severe and painful diarrhea. The diarrhea was almost projectile, painful and hot. It lasted a week. The patient had occasional cramps. In (b)(6) 2015 the patient also experienced weak bladder (serious criteria gsk medically significant) and chronic flatulence. Overuse of product was also reported. Poligrip ultra was discontinued in (b)(6) 2015. The symptoms began to ease (2 to 3 weeks duration). The outcome of the weak bladder and flatulence was unchanged. It was unknown if the reporter considered the weak bladder and flatulence to be related to poligrip ultra.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681138-2015-00013 |
| MDR Report Key | 4667479 |
| Report Source | 01,04 |
| Date Received | 2015-04-07 |
| Date of Report | 2015-02-19 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-03-19 |
| Date Added to Maude | 2015-05-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | P.O 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 ULTRA |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-04-07 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GSK DUNGARVAN STAFFORD MILLER |
| Manufacturer Address | DUNGARVAN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-07 |