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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. DBD-MAJOR GENERAL SHARED

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MEDLINE INDUSTRIES, INC. DBD-MAJOR GENERAL SHARED Back to Search Results
Catalog Number DYNJ64790
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2021
Event Type  Malfunction  
Manufacturer Narrative

It was reported, "the gauze had frayed when used on a patient during surgery. " email received by company representative, franciscan health, with additional information related to this incident. Reporter states, incident occurred (b)(6) 2021 during a total thyroid procedure. Reporter states, surgeon noted frayed pieces on his glove in the middle of the procedure. Reporter states, "i think they inspected the site to ensure no pieces were left and is unsure" how frayed material would have been removed from the surgical site had it needed to be. Reporter states, once the fraying was noticed, "they called the supervisor, passed off all items, got new raytecs. " reporter states patient was under general anesthesia but did not require additional anesthesia because of this incident. Sample has been returned for evaluation. Evaluation is pending. 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, "the gauze had frayed when used on a patient during surgery. ".

 
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Type of DeviceDBD-MAJOR GENERAL SHARED
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 Key11286035
MDR Text Key252210265
Report Number1423395-2021-00005
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/11/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYNJ64790
Device LOT Number20FDB723
Was Device Available For Evaluation? No
Date Returned to Manufacturer01/22/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
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: 02/05/2021 Patient Sequence Number: 1
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