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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC
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ETHICON INC. PROLENE SUTURE 18"(45CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number 8629H
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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 the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the device separated from the material.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient reported.
 
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Brand Name
PROLENE SUTURE 18"(45CM) 4-0 BLU
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8683924
Report Number2210968-2019-82564
Device Sequence Number1968418
Product Code GAW
UDI-Device Identifier10705031018044
UDI-Public10705031018044
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K133356
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/14/2019
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 Expiration Date11/30/2022
Device Catalogue Number8629H
Device Lot NumberLPJ730
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/14/2019
Initial Report FDA Received Date06/10/2019
Patient Sequence Number1
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