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..
[164032]
Pt was admitted for recess "m. R. ," advance "ir" both eyes and acovrevision both eyes, finectomy "so" post both eyes. Sterile mini drapes placed across eyes, forehead, and nose. When the drapes were removed, most of the right eyebrow was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015708 |
| MDR Report Key | 210538 |
| Date Received | 1999-02-17 |
| Date of Report | 1999-02-09 |
| Date of Event | 1999-02-04 |
| 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 | DRAPE # D 1035 NS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 204301 |
| Manufacturer | MEDICAL CONCEPTS DEVELOPMENT, INC. |
| Manufacturer Address | 2500 VENTURA DR. WOODBURY MN 551253927 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-02-17 |