MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 18"(45CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP497H
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.  attempts are being made to obtain the following information.  to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of the index procedure date of the index surgical procedure what were current symptoms following the index surgical procedure? onset date? when was suture spitting found post-op? on what tissue was the suture used? was another surgical intervention performed other than removal of suture? results? did the operating surgeon observe any anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? you reported ¿many patients went to hospital to cut suture¿.Were these patient events previously reported.If not, please provide the following additional information for each patient event: the patient demographic info: age, weight, bmi at the time of the index procedure date of the index surgical procedure what were current symptoms following the index surgical procedure? onset date? on what tissue was the suture used? was medical or surgical intervention performed? please describe.Current patient status? additional device evaluated by mfr: a needle-suture piece, an empty labeled winding former was returned for analysis.During the visual inspection of the opened sample, the swage and attachment area were as expected.In addition, body fluids along of the strand and the end cut that appears to be by the use of a surgical instrument could be observed.An unopened sample of product code vcp497, lot le8625 was returned for analysis.The sample was examined for visual defects appearance, color packages, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured).The packet was opened and during the visual inspection, the suture was correctly placed on the winding former and the suture was dispensed without problems and examined along of the strand, no defects or damaged were observed, the suture did not present defects.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the opened sample and representative sample, no defects were observed on the packet or the sutures.
Event or Problem Description
It was reported that the patient underwent cesarean section on an unknown date and suture was used to sew the subcutaneous tissue.Following the procedure, the suture thread came out from the skin.The patient may have gone to the hospital to cut suture through.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).The patient demographic info: age, weight, bmi at the time of the index procedure - unk date of the index surgical procedure - (b)(6).What were current symptoms following the index surgical procedure? onset date?- yes, onset date unknown when was suture spitting found post-op? - unk on what tissue was the suture used? - used on subcutaneous was another surgical intervention performed other than removal of suture? results? - unk did the operating surgeon observe any anomaly before, during, after the suture placement or during any re-operation?- no other relevant patient history/concomitant medications - unk what is physician¿s opinion as to the etiology of or contributing factors to this event? - related to suture what is the patient¿s current status?- stable.

• Brand Name: VICRYL PLUS SUTURE 18"(45CM) 3-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7580738
• Report Number: 2210968-2018-73369
• Device Sequence Number: 1524566
• Product Code: GAM
• UDI-Device Identifier: 10705031053823
• UDI-Public: 10705031053823
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: VCP497H
• Device Lot Number: LE8625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention