MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-01-17 for SUPER POLIGRIP ORIGINAL * manufactured by Glaxosmithkline Consumer Healthcare.
[417541]
Product evaluation summary: the unused product was not returned to the mfr. The lot number (r043821) provided by the consumer was not valid; it contains one extra digit. However, retain samples from lots r04382 and r04381 have been tested along with review of the release specifications. The retain samples met all requirements of release specifications at the time of release. Evaluation of the retain samples included visual and odour description and ph testing; all results were found to be within specifications. Please note that the date of mfr for both lot numbers is 12/2004. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
[15687843]
This case was reported by a consumer's family member and described the occurrence of a semi-coma in patient who used super poligrip original denture adhesive cream for loose dentures. The consumer called with a product question. A physician or other health care professional has not verified this report. Concurrent medical conditions included diabetes. On an unknown date, the patient started using super poligrip original denture adhesive cream. At an unknown time after starting poligrip, the patient experienced a semi-coma due to their diabetes. The patient was hospitalized. The outcome of the event is unknown. The consumer refused to provide additional information. Manufacturer's comment - the manufacturer's report number for this case is 9681138-2004-00049.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00049 |
| MDR Report Key | 566298 |
| Report Source | 04 |
| Date Received | 2005-01-17 |
| Date of Report | 2005-01-13 |
| Date Mfgr Received | 2004-12-23 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2005-01-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1500 LITTLETON RD. |
| Manufacturer City | PARRISPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE,IRELAND |
| Manufacturer Street | CLOCHERANE, YOUGHAL ROAD |
| Manufacturer City | DUNGARVAN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER POLIGRIP ORIGINAL |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KCO |
| Date Received | 2005-01-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | R04382 OR R04381 |
| 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 | 556083 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2005-01-17 |