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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVID MEDICAL/OWENS & MINOR DISTRIBUTION, INC. CUSTOM CATARACT PACK; EYE TRAY
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AVID MEDICAL/OWENS & MINOR DISTRIBUTION, INC. CUSTOM CATARACT PACK; EYE TRAY Back to Search Results
Catalog Number WILF013-32
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2019
Event Type  malfunction  
Event Description
Scrub technician upon opening the custom pack to prepare observed debris on the patient drape.(b)(6) operating rom #4 case #3 on (b)(6) 2019 about 1045hrs no staff or patient injured, pack destroyed drape turned over for verification to manufacturer.Psr # (b)(4) submitted.Fda report filed.Certified scrub technician opened the pack.Product sterile and packed in manufactured packaging expire on 22022-01-01, lot # 1373264.Product should be free of foreign debris.Incident of this nature is not uncommon and is continued to be reported as they occur.Vendor poc for the whasc notified.(b)(6).(b)(4).
 
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Brand Name
CUSTOM CATARACT PACK
Type of Device
EYE TRAY
Manufacturer (Section D)
AVID MEDICAL/OWENS & MINOR DISTRIBUTION, INC.
MDR Report Key9290854
MDR Text Key165956122
Report NumberMW5090931
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 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2022
Device Catalogue NumberWILF013-32
Device Lot Number1373264
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2019
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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