MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-27 for CUSHION GRIP * manufactured by Schering-plough Healthcare Products, Inc..
[226602]
"pt bottom lip swells really big, it gets three times the size it should be". Pt went to md and was referred to a head and neck specialist. Suspected cushion grip. Dr wanted ingredients and there was not any labeling for ingredients. Informed to go to pharmacist and he had no info either; family member given toll free number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022493 |
| MDR Report Key | 344064 |
| Date Received | 2001-07-27 |
| Date of Report | 2001-07-27 |
| Date of Event | 2000-12-01 |
| Date Added to Maude | 2001-07-31 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | CUSHION GRIP |
| Generic Name | ADHESIVE |
| Product Code | KOP |
| Date Received | 2001-07-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 22492004 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 333400 |
| Manufacturer | SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | * MEMPHIS TX * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-27 |