MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-19 for ALLEGIENCE 1061 SEY26BSWHA manufactured by Allegience.
[240794]
Drape used during surgery. When drape was removed by physician, part of pt's eyebrow was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 377816 |
| MDR Report Key | 377816 |
| Date Received | 2002-02-19 |
| Date of Report | 2002-02-19 |
| Date of Event | 2002-02-06 |
| Date Facility Aware | 2002-02-06 |
| Report Date | 2002-02-19 |
| Date Reported to FDA | 2002-02-19 |
| Date Reported to Mfgr | 2002-02-19 |
| Date Added to Maude | 2002-02-25 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEGIENCE |
| Generic Name | EYE DRAPE |
| Product Code | HMT |
| Date Received | 2002-02-19 |
| Returned To Mfg | 2002-02-08 |
| Model Number | 1061 |
| Catalog Number | SEY26BSWHA |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 366863 |
| Manufacturer | ALLEGIENCE |
| Manufacturer Address | 1450 WAUKEGAN RD MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-02-19 |