MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2008-03-03 for CUSHION GROP ( DEVICE NO ACTIVE INGREDIENTS) manufactured by Schering Corp..
[807922]
A spontaneous report from an (b) (6) female consumer. The consumer's medical history and concomitant medications were not provided. The consumer initiated cushion grip denture adhesive on (b) (6) 2008. After using the product, the consumer experienced a burning sensation. On (b) (6), she noticed blister and tongue swelling. She was brought to a hospital emergency room by ambulance and was kept in hospital overnight. The consumer was diagnose with allergic reaction to this product. She received iv steroid treatment and was discharged the next day. Her blisters are finally healing. No further details can be obtained.
Patient Sequence No: 1, Text Type: D, B5
[8043322]
(b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210048-2008-00001 |
| MDR Report Key | 1006503 |
| Report Source | 01,04 |
| Date Received | 2008-03-03 |
| Date of Event | 2008-01-16 |
| Date Mfgr Received | 2008-01-29 |
| Date Added to Maude | 2009-12-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN BREWER |
| Manufacturer Street | 3030 JACKSON AVENUE |
| Manufacturer City | MEMPHIS TN 38151 |
| Manufacturer Country | US |
| Manufacturer Postal | 38151 |
| Manufacturer Phone | 9013202627 |
| Manufacturer G1 | SCHERING CORP. |
| Manufacturer Street | 13900 N.W. 57TH COURT |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSHION GROP ( DEVICE NO ACTIVE INGREDIENTS) |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2008-03-03 |
| Lot Number | LBJ04 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHERING CORP. |
| Manufacturer Address | MIAMI, LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2008-03-03 |