MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-08-30 for POLIGRIP * manufactured by Gsk.
[356797]
Pt who received poligrip (super poligrip extra care with poliseal) over a period of 4 mos for loose dentures. A physician or other health care professional has not verified this report. The pt's past medical history included allergy to morphine, angina pectoris, angioplasty, asthma and codeine allergy. Concurrent medications included hydrocodone, bextra, hydrochlorothiazide and inhalers. In 2004 the pt started poligrip (dental). At an unk time after starting poligrip, the pt was diagnosed with possible metastatic cancer; pt had two biopsies performed in 2004 and was hospitalized overnight. The pt also experienced gum pain and poligrip was discontinued; this event is unresolved.
Patient Sequence No: 1, Text Type: D, B5
[16301924]
Mfr's comment: the mfr report number for this case is 9681138-2004-00017. Super poligrip extra care with poliseal is manufactured. In the absence of further data or supportive trends, quality testing is unlikely to clarify the adverse event report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00017 |
| MDR Report Key | 541201 |
| Report Source | 04 |
| Date Received | 2004-08-30 |
| Date of Report | 2004-08-12 |
| Date Mfgr Received | 2004-07-23 |
| Device Manufacturer Date | 2003-12-01 |
| Date Added to Maude | 2004-08-31 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1500 LITTLETON RD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE, IRELAND |
| Manufacturer Street | YOUGHAL RD CLOCHERANE |
| Manufacturer City | DUNGARVEN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-08-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | R03494 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 530534 |
| Manufacturer | GSK |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2 | 1. Hospitalization; 2. Other | 2004-08-30 |