MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-02-06 for EFFERGRIP DENTURE ADHESIVE CREAM UNK manufactured by Pfizer Inc..
[18916759]
A patient began using effergrip denture adhesive cream (carboxymethylcellulose sodium, maleic anhydride, methyl vinyl ether) 4-5 times daily to hold his dentures approximately in 2004. The consumer reported that he has been using the product 4-5 times daily since the product only holds his dentures for about 2 hours. As of dec 2005 he was continuing to use the product. Additional information received by pfizer in jan 2006 upgrades this case to serious: the patient reported he has been using the product for one and a half years, 6 times a day and has been having sleep apnea and central nervous system disorder described as facioscapulohumeral. He no longer uses the product and the outcome of the events is unknwon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246407-2006-00001 |
| MDR Report Key | 672752 |
| Report Source | 04 |
| Date Received | 2006-02-06 |
| Date of Report | 2006-01-12 |
| Date of Event | 2004-01-01 |
| Date Mfgr Received | 2006-01-09 |
| Date Added to Maude | 2006-02-10 |
| 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 | 201 TABOR ROAD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733850704 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EFFERGRIP DENTURE ADHESIVE CREAM |
| Generic Name | DENTURE PRODUCT |
| Product Code | KOQ |
| Date Received | 2006-02-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 102840 |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 662073 |
| Manufacturer | PFIZER INC. |
| Manufacturer Address | * MORRIS PLAINS NJ 07950 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-02-06 |