MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for CUSTOM CATARACT PACK WILF013-32 manufactured by Avid Medical, Inc., A Medical Action Ind. Company 305.
[180310886]
Scrub tech upon opening the custom pack to prepare, observed human hair inside the sterile pack. (b)(6) operating room #3 on (b)(6) 2020 about 0715hrs. No staff or pt injured, pt hadn't rolled into the room at that time. Psr #(b)(4) submitted. Fda report filed. Certified scrub tech opened the pack. Product sterile and packed in manufactured packaging expire on 01/01/2020, lot #1382717. Product should be free of foreign debris. Vendor poc for the whasc notified, (b)(6). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093066 |
| MDR Report Key | 9728693 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-12 |
| Date Added to Maude | 2020-02-19 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM CATARACT PACK |
| Generic Name | EYE TRAY |
| Product Code | OJK |
| Date Received | 2020-02-18 |
| Catalog Number | WILF013-32 |
| Lot Number | 1382717 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVID MEDICAL, INC., A MEDICAL ACTION IND. COMPANY 305 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |