MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2001-05-18 for CUSTOM PACK CUSTOM PAK manufactured by Alcon - Houston.
[15449768]
Reporter noted cornea protector left a circle on pt's eye when removed. Pt's eye required scrapping of epithelium to remove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644019-2001-00016 |
| MDR Report Key | 334144 |
| Report Source | 00,06 |
| Date Received | 2001-05-18 |
| Date of Event | 2001-03-15 |
| Date Mfgr Received | 2001-04-27 |
| Date Added to Maude | 2001-05-24 |
| 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 Contact | NED LUCE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175686410 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM PACK |
| Generic Name | SURGICAL PACK |
| Product Code | MOE |
| Date Received | 2001-05-18 |
| Model Number | CUSTOM PAK |
| Catalog Number | CUSTOM PAK |
| Lot Number | 190245H |
| ID Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 323492 |
| Manufacturer | ALCON - HOUSTON |
| Manufacturer Address | 2650 WEST BELLFORT HOUSTON TX 770545008 US |
| Baseline Brand Name | CUSTOM PAK |
| Baseline Generic Name | SURGICAL PAK |
| Baseline Model No | CUSTOM PAK |
| Baseline Catalog No | CUSTOM PAK |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-05-18 |