MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 5-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP421H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.A manufacturing record evaluation was performed for the finished device lot number mlz458 and no non-conformances related to the reported complaint condition were identified.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.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? when did the bleeding occur? what was the source and triggering event of bleeding? what was the volume of blood loss? how was the bleeding treated? how did the suture needle pull off result in the incision bleeding? please explain.Please clarify ¿the sew was not in place¿? please clarify ¿the treatment effect was poor.¿? please describe any medical/surgical intervention required including results.Was the patient¿s treatment or post-operative care altered in anyway due to the intra-op bleeding? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? were there any adverse patient consequences? what is the patient's current status? device being returned? trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 275 g/m.
Event or Problem Description
It was reported that a patient underwent a myomectomy on (b)(6) 2021 and suture was used.During the procedure, the suture pulled off the needle with suturing the hysteromyoma, resulting in incision bleeding, and the sew was not in place.The treatment effect was poor.The bleeding site of the tissue was urgently treated immediately.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/8/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure: 45 years old; female; other information is unknown.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)?---laparoscopic procedure.Please clarify ¿the sew was not in place¿?: the tissue should be sewed well with the suture, but it wasn't sewed perfectly because the pulling off suture needle happened.Please clarify ¿the treatment effect was poor.¿?: the problem of pulling off suture needle happened, so the tissue wasn't sewed perfectly because the pulling off suture needle happened.Device being returned? no, the sample isn't available for return.The following information was requested but unavailable: on what tissue was the suture used? unk.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unk.How was the suture placed (interrupted or continuous)?-unk.How was the suture originally tied (multiple knots, square knot, etc.)? unk.When did the bleeding occur? unk.What was the source and triggering event of bleeding? unk.What was the volume of blood loss? unk.How was the bleeding treated? unk.How did the suture needle pull off result in the incision bleeding? please explain.Unk.Please describe any medical/surgical intervention required including results.Unk was the patient¿s treatment or post-operative care altered in anyway due to the intra-op bleeding? unk.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? unk.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unk.Were there any adverse patient consequences? unk.What is the patient's current status? unk.Nce there is any update, we will update the information.

• Brand Name: VCL+ UD 27IN 5-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13230190
• Report Number: 2210968-2022-00296
• Device Sequence Number: 17117867
• Product Code: GAM
• UDI-Device Identifier: 10705031053076
• UDI-Public: 10705031053076
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: VCP421H
• Device Catalogue Number: VCP421H
• Device Lot Number: MLZ458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/16/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female