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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC. CATARACT TENAYA SURGERY CENTER

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MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC. CATARACT TENAYA SURGERY CENTER Back to Search Results
Model Number VAL009CATEA
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  Malfunction  
Manufacturer Narrative

It was reported, "blue fibers in the custom pack are evident on the instruments within the pack. Fibers have been found in the eye as well. " specifically mentioned, "it was inside the eye, on top of the lens and was removed with utrada forceps, (b)(6) 2021 by md. " additional emails received by facility representatives, (b)(6), who provided additional information in regards to this reported incident. Reporters confirm incident occurred (b)(6) 2021. Reporter states, "product was not thoroughly inspected prior to use; issue was identified during procedure. " "physician noticed lint in patient's eye and on instruments. " per initial complaint report, lint removed with utrada forceps by physician that day ((b)(6) 2021). Reporter states, "no serious injury, follow-up care or medical intervention needed. " no additional general anesthesia or sedation was needed or provided after the reported incident. Reporter states, "no adverse events reported during post-op phone call. " no samples are available for return and evaluation. Photograph sent. No further information has been provided. Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

 
Event Description

It was reported, "blue fibers in the custom pack are evident on the instruments within the pack. Fibers have been found in the eye as well. " specifically mentioned, "it was inside the eye, on top of the lens and was removed with utrada forceps, (b)(6) 2021 by md. ".

 
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Brand NameMEDLINE INDUSTRIES, INC.
Type of DeviceCATARACT TENAYA SURGERY CENTER
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
teresa maynard
three lakes drive
northfield, IL 60093
2249311514
MDR Report Key11752484
MDR Text Key250458950
Report Number1423395-2021-00021
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 Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVAL009CATEA
Device Catalogue NumberVAL009CATEA
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/30/2021 Patient Sequence Number: 1
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