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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. CATARACT PACK

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MEDLINE INDUSTRIES INC. CATARACT PACK Back to Search Results
Catalog Number DYNJ62204A
Device Problems Material Fragmentation (1261); Contamination /Decontamination Problem (2895)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/01/2019
Event Type  Malfunction  
Manufacturer Narrative

It was reported that during follow up after an unidentified eye procedure, the gauze was identified to have linted into the patient's eye. The linted material was required to be retrieved from the patient's eye during the follow up visit by the clinician. After multiple good-faith attempts, the reporting facility was unable or unwilling to provide additional patient, product, or procedural information to the pack manufacturer. No impact or adverse effect to the patient was originally reported to the pack manufacturer. The actual pack involved in the reported incident was not returned to the pack manufacturer for evaluation. A root cause for the reported incident could not be determined. Due to the reported need for medical intervention to retrieve the linted gauze material from the patient's eyes, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.

 
Event Description

It was reported that the gauze linted into the patients eye during an unidentified eye procedure.

 
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Type of DeviceCATARACT PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093
8476434960
MDR Report Key8955888
MDR Text Key162646597
Report Number1423395-2019-00031
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 USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 09/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYNJ62204A
Device LOT Number19CBR358
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/03/2019 Patient Sequence Number: 1
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