MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-01-21 for EXTRA STRENGTH EFFERGRIP manufactured by Warner Lambert Co..
[43045]
Physician reported that on 1/4/97 a 32-yr-old female pt experinced an anaphylactic reaction after using denture adhesive for her dentures. Within two minutes of using the product, the pt's lips became tingly and her tongue became swollen that she couldn't put back in her mouth. The pt was admitted to an icu where she was treated with epinephrine and steroids. The pt had high blood pressures and was given vasotec. Pt was released 24 hrs later after her blood pressure was reduced to normal. The pt has fully recovered. The pt's physician reports that approx three yrs ago she exprienced the same exact symptoms after using the product and was treated in the icu with epinephrine and steroids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2510770-1997-00001 |
| MDR Report Key | 63906 |
| Report Source | 05 |
| Date Received | 1997-01-21 |
| Date of Report | 1997-01-09 |
| Date of Event | 1997-01-04 |
| Date Mfgr Received | 1997-01-06 |
| Date Added to Maude | 1997-01-24 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTRA STRENGTH EFFERGRIP |
| Generic Name | DENTURE ADHESIVE CREAM |
| Product Code | KOP |
| Date Received | 1997-01-21 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 64055 |
| Manufacturer | WARNER LAMBERT CO. |
| Manufacturer Address | 170 TABOR RD MORRIS PLAINS NJ 07950 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 1997-01-21 |