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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. DYNJ CUSTOM PACK SURGICAL PACK

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MEDLINE INDUSTRIES, INC. DYNJ CUSTOM PACK SURGICAL PACK Back to Search Results
Catalog Number DYNJ54802B
Device Problem Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2017
Event Type  Malfunction  
Event Description

During the procedure, the surgeon noted that a piece of the 18x18 had frayed. She removed it and the sponge from the sterile field. The procedure was completed as planned with no harm to the patient. Per site reporter: this is an ongoing issue that is reported directly to our sales representative.

 
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Brand NameDYNJ CUSTOM PACK
Type of DeviceSURGICAL PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key7040410
MDR Text Key92353246
Report Number7040410
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/17/2017
Is This An Adverse Event Report? No
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? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2017
Device Age0 yr
Event Location Hospital
Date Report TO Manufacturer11/06/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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