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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC (COVIDIEN) COVIDIEN GAUZE IN LUMBAR PACK-LF

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MEDTRONIC (COVIDIEN) COVIDIEN GAUZE IN LUMBAR PACK-LF Back to Search Results
Catalog Number DYNJ27379M
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
It was reported that during a microdiscectomy procedure, raytec fibers from the covidien gauze were found to have fallen into the surgical site. The method used to retrieve the raytec fibers from the surgical site was not identified by the reporting facility. No impact to the patient, the patient's stability, or the patient's plan of care was reported. No impact to the procedure was reported. No serious injury or follow-up care was reported. No sample was available to be returned for evaluation. No additional information was provided by the reporting facility. A third-party notification was sent to the manufacturer of the raytec gauze. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported that during a microdiscectomy procedure, raytec fibers from the covidien gauze were found to have fallen into the surgical site.
 
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Type of DeviceCOVIDIEN GAUZE IN LUMBAR PACK-LF
Manufacturer (Section D)
MEDTRONIC (COVIDIEN)
710 medtronic parkway
minneapolis MN 55432 5604
Manufacturer Contact
nigel vilches
three lakes drive
northfield, IL 60093-2753
2249311458
MDR Report Key8010849
MDR Text Key125281318
Report Number1423395-2018-00056
Device Sequence Number1
Product Code OJH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDYNJ27379M
Device Lot Number18FBV501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2018
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: 10/26/2018 Patient Sequence Number: 1
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