MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-03-01 for EFFERDENT PLUS W/ FRESHBURST LISTERINE UNK manufactured by Pfizer Inc..
[405170]
Investigation summary received on 5/2/2005 from pfizer's quality operations/product complaints group: "a review of the lot records found no deviations that could be associated with the reported complaint. Release testing performed found the lot met all specifications for description: disintegration time, ph, fade time, and available oxygen. Analytical testing of retain samples of the reported lot found the lot met all specifications for description, disintegration time, ph, fade time, and available oxygen. This is the first complaint registered on this lot since the date of release. No further investigation can be completed at this time. "
Patient Sequence No: 1, Text Type: D, B5
[21255861]
A consumer reports that their spouse used one tablet of efferdent plus denture cleanser with fresh burst listerine (sodium perborate monohydrate, potassium monopersulfate) one per week beginning in approximately in 1995 (exact date unspecified) to clean their dentures. Beginning in 2005, pt had pneumonia and was hospitalized. While in the hospital, pt had unspecified laboratory tests (results unknown). The consumer's spouse died form an unspecified cause on an unknown date in feb 2005.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246407-2005-00003 |
| MDR Report Key | 576973 |
| Report Source | 04 |
| Date Received | 2005-03-01 |
| Date of Report | 2005-02-25 |
| Date of Event | 2005-01-31 |
| Date Mfgr Received | 2005-02-18 |
| Date Added to Maude | 2005-03-03 |
| 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 | EFFERDENT PLUS W/ FRESHBURST LISTERINE |
| Generic Name | DENTURE PRODUCT |
| Product Code | JER |
| Date Received | 2005-03-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | CK15N4V |
| 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 | 566813 |
| Manufacturer | PFIZER INC. |
| Manufacturer Address | * MORRIS PLAINS NJ 07950 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2005-03-01 |