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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC. THE SURGERY CENTER CATARACT Back to Search Results
Model Number VAL002CATSD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 09/30/2020
Event Type  Injury  
Manufacturer Narrative

It was reported that following a cataract surgery where the procedure pack was used, the patient experienced an unspecified infection. Reportedly, the patient was referred to a retinal specialist where unspecified cultures were drawn and an unspecified antibiotic treatment was started. The patient has required follow-up care from the retinal specialist. No additional information was provided by the reporting facility and it is unknown what component(s) from the procedure pack were used at the time of the cataract surgery. No sample was returned to the pack manufacturer for evaluation. A root cause for the reported incident was unable to be determined. Due to the reported infection and the need for medical intervention, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.

 
Event Description

It was reported that a patient experienced an unspecified infection.

 
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Brand NameMEDLINE INDUSTRIES, INC.
Type of DeviceTHE SURGERY CENTER CATARACT
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
nigel vilches
three lakes drive
northfield, IL 60093-2753
2249311458
MDR Report Key10963417
MDR Text Key220147408
Report Number1423395-2020-00041
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 DISTRIBUTOR,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/14/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVAL002CATSD
Device Catalogue NumberVAL002CATSD
Device LOT Number20BBX711
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/07/2020 Patient Sequence Number: 1
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