MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number VCP359H

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.How was the vicryl suture placed (interrupted or continuous)? can you explain where the patient felt pain (abdominal incision or vagina)? can you explain if the suture photo is a sample of the suture used? was the photo of the suture that ¿came out from vagina¿? what are the results of the cultures of the endocervical canal? did the patient have any symptoms of infection? what was the indication for the antibiotics? what is the current condition of the patient?.

Event Description

It was reported that a (b)(6) female patient underwent a caesarean section procedure on (b)(6) 2017 and suture was used.The suture was used on the mucous layer and myometrium.There were no anomalies during the procedure.Post operatively the patient felt pain on the wound and returned to the hospital on (b)(6) 2017.It was noted that the suture came out from the vagina.The patient was treated with intravenous antibiotics and oxytocin.The patient endocervical canal secretion is being tested and the patient is being monitored at the hospital.

Manufacturer Narrative

Additional information was requested and the following was obtained: how was the vicryl suture placed (interrupted or continuous)? continuous.Can you explain where the patient felt pain (abdominal incision or vagina)? wound.Can you explain if the suture photo is a sample of the suture used? yes.Was the photo of the suture that ¿came out from vagina¿? yes.What are the results of the cultures of the endocervical canal? unk did the patient have any symptoms of infection? unk what was the indication for the antibiotics? unk.What is the current condition of the patient? unk.

Manufacturer Narrative

Date sent to the fda: 07/20/2017 additional information: a vicryl suture piece and a filament of the unknown suture was received for analysis.During the visual inspection of the vicryl suture piece, it could be observed a strand used piece with body fluids and cut in the ends of the strand approximately of 3.00¿ inches along.No conclusion could be reached as how suture came out, since the sample was received used and exposed to the environment, so the degradation process has already begun.The filaments received present damaged and is not possible to determine if belongs to the suture.

• Brand Name: VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam street; san angelo TX 76905
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6604412
• MDR Text Key: 76410788
• Report Number: 2210968-2017-32355
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: VCP359H
• Device Lot Number: LA7014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR