MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2002-01-04 for CUSHION GRIP * manufactured by Schering Corporation.
[212619]
A consumer reported that pt experienced tongue swelling within 10 minutes of applying cushion grip (sunday). Tongue began to swell to the point of obstructing pt's breathing. Pt was taken to the er where pt was treated with solumedrol (methylprednisone) and benadryl (diphenhydramine) and epinephrine for apparent anaphylactic shock. Pt was discharged on monday when the swelling had subsided. On tuesday pt's voice got gruff and pt developed hives all over pt body (although pt had not used cushion grip again). Pt was taken back to the er and treated with the same drugs noted above, but was sent home with prednisone and diphenhydramine. Pt's dr believes that cushion grip was the cause of pt's reaction and that the responses noted on tuesday were due to the contact with cushion grip on sunday. The pt has knwon allergies to sulfa drugs and penicillin. Pt had quadruple by-pass surgery approx two years ago and has been taking dyazide, ranitidine, and aspirin on a daily basis ever since.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1010370-2001-00001 |
| MDR Report Key | 369616 |
| Report Source | 04,05 |
| Date Received | 2002-01-04 |
| Date Mfgr Received | 2001-08-23 |
| Date Added to Maude | 2002-01-07 |
| 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 | 0 |
| Manufacturer Street | 2000 GALLOPING HILL ROAD |
| Manufacturer City | KENILWORTH NJ 07033 |
| Manufacturer Country | US |
| Manufacturer Postal | 07033 |
| Manufacturer Phone | 9739217435 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSHION GRIP |
| Generic Name | NON-CLASSIFIED |
| Product Code | EHS |
| Date Received | 2002-01-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 358745 |
| Manufacturer | SCHERING CORPORATION |
| Manufacturer Address | 13900 NORTHWEST 57TH COURT MIAMI LAKES FL 33014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2002-01-04 |