• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVID MEDICAL, INC., A MEDICAL ACTION IND. COMPANY 305 CUSTOM CATARACT PACK EYE TRAY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AVID MEDICAL, INC., A MEDICAL ACTION IND. COMPANY 305 CUSTOM CATARACT PACK EYE TRAY Back to Search Results
Catalog Number WILF013-32
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2020
Event Type  malfunction  
Event Description
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCUSTOM CATARACT PACK
Type of DeviceEYE TRAY
Manufacturer (Section D)
AVID MEDICAL, INC., A MEDICAL ACTION IND. COMPANY 305
MDR Report Key9728693
MDR Text Key180310886
Report NumberMW5093066
Device Sequence Number1
Product Code OJK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberWILF013-32
Device Lot Number1382717
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-