MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-17 for FIXADENT COMPLETE * manufactured by Procter & Gamble Manufacturing Co.
[286615]
Pt stated that they have been a diabetic for several years. Currently they are taking lantus and humalog insulin. Pt takes eight units of humolog in the morning and at supper. Prior to bedtime, pt takes thirty units of lantus. Pt stated that they began using fixadent complete for the adhesion of their dentures in november 2002. Pt immediately noticed that their blood sugar readings were erratic. Pt monitors their blood glucose levels 4-6 times a day. Pt averages @ 100. Pt stated that they used the fixadent for approx two weeks and blood sugars averaged @ 120. Pt stated that they had to supplement with the humalog. During this time, blood sugar readings were as high as 240. In december 2002, pt discontinued the use of fixadent and within one day they observed that blood sugar levels returned to the norm. Pt stated that they contacted the mfr and they stated that no sugar was in the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003451 |
| MDR Report Key | 445918 |
| Date Received | 2002-12-17 |
| Date of Report | 2002-12-17 |
| Date of Event | 2002-11-19 |
| Date Added to Maude | 2003-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXADENT COMPLETE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOQ |
| Date Received | 2002-12-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 2.2 OUNCES BOX |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 434891 |
| Manufacturer | PROCTER & GAMBLE MANUFACTURING CO |
| Manufacturer Address | 6200 BRYAN PARK ROAD BROWN SUMMIT NC 27214 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-12-17 |