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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES DYNJ CUSTOM PACK CUSTOM SURGICAL PACK

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MEDLINE INDUSTRIES DYNJ CUSTOM PACK CUSTOM SURGICAL PACK Back to Search Results
Catalog Number DYNJ54802B
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2017
Event Type  Malfunction  
Event Description

During a procedure, the st noticed that the 18x18 from the major pack had frayed. The 18x18s were removed from the sterile field and saved for return. New sponges were introduced, and the procedure was completed as planned with no harm to the patient. No fragments were left in the patient. Per site reporter: this event was reported to the manufacturer sales rep. He will be filing a complaint within medline's system.

 
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Brand NameDYNJ CUSTOM PACK
Type of DeviceCUSTOM SURGICAL PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES
1204 townline rd
mundelein IL 60060
MDR Report Key7147299
MDR Text Key95806617
Report Number7147299
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 12/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberDYNJ54802B
Device LOT Number17HD2663
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/21/2017
Device Age0 yr
Event Location Hospital
Date Report TO Manufacturer12/21/2017
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

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