MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-18 for CATARACT CUSTOM DRAPE PACK * manufactured by Alcon Laboratories, Inc.
[4652082]
Cataract custom pack contained a foreign speck of some material. Discovered during case set-up. New pack obtained. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3893439 |
| MDR Report Key | 3893439 |
| Date Received | 2014-06-18 |
| Date of Report | 2014-06-18 |
| Date of Event | 2013-11-04 |
| Report Date | 2014-06-18 |
| Date Reported to FDA | 2014-06-18 |
| Date Reported to Mfgr | 2014-06-25 |
| Date Added to Maude | 2014-06-25 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | CATARACT CUSTOM DRAPE PACK |
| Generic Name | DRAPE, SURGICAL |
| Product Code | HMT |
| Date Received | 2014-06-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 1503113H |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DAY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC |
| Manufacturer Address | 6201 SOUTH FREEWAY FT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-18 |