MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-02-10 for SUPER POLIGRIP DENTURE ADHESIVE CREAM-UNIDENTIFIED * manufactured by Glaxosmithkline.
[19900676]
A pt, who was hospitalized for an unspecified reason, experienced respiratory arrest in 2002, because their dentures slipped off from their gums, became lodged in their throat and blocked their airway. The nurse reported that the attending physician had to "pry" the pt's mouth open to remove the denture from their throat because the super poligrip had "sealed their gums together". The nurse reported that the consumer recovered once their dentures were removed but she felt that "the situation could have been worse". The nurse refused to provide additional info. Mfr comment: super poli-grip denture adhesive cream, mfg by block drug company, now glaxosmithkline, has been indentified as the suspect product in this case. The exact identity of the product is unknown, but it is believed to have been mfg in ireland. No correctiue actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2003-00001 |
| MDR Report Key | 442193 |
| Report Source | 05 |
| Date Received | 2003-02-10 |
| Date of Report | 2003-02-06 |
| Date of Event | 2002-02-01 |
| Date Mfgr Received | 2003-01-08 |
| Date Added to Maude | 2003-02-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1500 LITTLETON ROAD |
| Manufacturer City | PARSIPPANY NJ 070543884 |
| Manufacturer Country | US |
| Manufacturer Postal | 070543884 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER POLIGRIP DENTURE ADHESIVE CREAM-UNIDENTIFIED |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2003-02-10 |
| 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 | 431171 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | 1500 LITTLETON ROAD PARSIPPANY NJ 070543884 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-02-10 |