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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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ETHICON INC. PROLENE SUTURE 18"(45CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE Back to Search Results
Catalog Number 8318H
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/12/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event or Problem Description
It was reported that a patient underwent a carotid endarterectomy on (b)(6) 2019 and suture was used.During the procedure, the needle popped off the suture into the patient.The procedure was completed by using a new box of suture from a different lot.There were no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
PROLENE SUTURE 18"(45CM) 6-0 BLU
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9559215
Report Number2210968-2020-00175
Device Sequence Number19401945
Product Code GAW
UDI-Device Identifier10705031014305
UDI-Public10705031014305
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K133356
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number8318H
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/12/2019
Initial Report FDA Received Date01/07/2020
Patient Sequence Number1
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