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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MAJOR KIT

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MEDLINE INDUSTRIES INC. MAJOR KIT Back to Search Results
Catalog Number DYNJ54802B
Device Problem Material Frayed (1262)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/01/2017
Event Type  Injury  
Manufacturer Narrative

It was reported that during a breast reconstruction procedure the sponge frayed inside of the patient. The surgeon removed the sponge from the sterile field and the pieces of sponge from the operative space. There was no serious injury identified or follow up medical care required. There was no impact to the patient or the procedure being performed. General anesthesia was used however there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. The patient was reported to be doing well with no adverse outcome. No additional details are available. A sample has not yet been returned for evaluation however, due to the reported incident, and in abundance of caution this medwatch is being filed. Should additional relevant information become available a supplemental report will be submitted.

 
Event Description

It was reported that during a procedure, pieces of the lap sponge frayed inside the patient.

 
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Type of DeviceMAJOR KIT
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes dr.
northfield IL 60093
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093
8476434960
MDR Report Key7122782
MDR Text Key95050736
Report Number1423395-2017-00031
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 USER FACILITY
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 12/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberDYNJ54802B
Device LOT Number17GD0664
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/07/2017
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 Initial

Patient TREATMENT DATA
Date Received: 12/15/2017 Patient Sequence Number: 1
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