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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 30CM M0.2 10/0 U-20 SUTURE, NONABSORBABLE, SYNTHETIC

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ETHICON INC. ETHILON BLK 30CM M0.2 10/0 U-20 SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number U7003
Device Problems Crack (1135); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

 
Event Description

It was reported that a patient underwent a glaucoma procedure on an unknown date in (b)(6) 2019 and suture was used. The suture left a larger hole than normal in the tissue. Upon closer inspection, it was seen that the needle end was not properly closed around the suture and excess glue in the back of the needle. As a complication, there was an increased leakage after the needle stick but the patient was not injured. The procedure was not delayed and was completed successfully. There were no patient consequences reported.

 
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Brand NameETHILON BLK 30CM M0.2 10/0 U-20
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9171656
MDR Text Key161785847
Report Number2210968-2019-88506
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/11/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/09/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberU7003
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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