MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-09-28 for POLIGRIP CREAM * manufactured by Glaxosmithkline, Consumer Healthcare.
[15686305]
This case was reported by a consumer and described the occurrence of gastric bypass surgery in a pt who used poligrip (super poligrip original denture adhesive cream) for loose dentures. The consumer contacted the mfr regarding a product inquiry and product complaint. A physician or other health care professional has not verified this report. In 2001 the pt started poligrip (dental). In 2001 the pt underwent a gastric bypass surgery and in 7/2004 pt had benign fatty tumors removed from their abdomen. Treatment with poligrip was continued. The outcome of the events is unk. The consumer refused to provide additional info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2650037-2004-00003 |
| MDR Report Key | 546981 |
| Report Source | 04 |
| Date Received | 2004-09-28 |
| Date of Report | 2004-09-28 |
| Date of Event | 2001-01-01 |
| Date Mfgr Received | 2004-09-01 |
| Date Added to Maude | 2004-10-05 |
| 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 | DENTCO FACILITY |
| Manufacturer Street | PR STATE RD #3 KILOMETER 76.9 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-09-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 536389 |
| Manufacturer | GLAXOSMITHKLINE, CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-28 |