MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-02-17 for MINER EYE PACK * manufactured by Medical Concepts Development, Inc..
[173435]
Pt admitted for recess bilateral eyes. Upon completion of the surgery, the drapes with adhesive were being removed and most of the pt's eyelashes and eyebrows were removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015707 |
| MDR Report Key | 210536 |
| Date Received | 1999-02-17 |
| Date of Report | 1999-02-08 |
| Date of Event | 1999-01-07 |
| Date Added to Maude | 1999-02-23 |
| 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 |
| 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 | MINER EYE PACK |
| Generic Name | CUSTOM PACK-DRAPE FOR EYE SURGERY |
| Product Code | HMT |
| Date Received | 1999-02-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 204299 |
| Manufacturer | MEDICAL CONCEPTS DEVELOPMENT, INC. |
| Manufacturer Address | 2500 VENTURA DRIVE WOODBURY MN 551253927 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-02-17 |