MAUDE Adverse Event Report: ETHICON INC. VCL MESH KNIT UD 12INX12IN; MESH, SURGICAL, POLYMERIC

Model Number VKML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Fatigue (1849); Itching Sensation (1943); Nausea (1970); Pain (1994); Local Reaction (2035); Skin Irritation (2076); Obstruction/Occlusion (2422)

Event Date 03/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances 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.Additional information was requested and the following was obtained: please provide procedure date: (b)(6) 2020.What date did the symptoms occur on? (b)(6) 2020.Is there any surgical intervention planned? no.Any medical treatment provided? yes if yes, please provide medicine name, strength and dose.Allopurinol for joint pain 100mg/day.Were prescription steroids administered? yes twice.Were antibiotics prescribed? no.Current patient status? extreme joint pain, nausea, extreme fatigue, hot over the area and itchy.

Event Description

It was reported that a patient underwent an umbilical hernia procedure on (b)(6) 2020 and the mesh was implanted.It was reported that after the procedure the patient has experienced achy joints, extreme fatigue, tiredness, upset stomach, diarrhea, nausea, itching and hotness in stomach where mesh was inserted.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested and the following was obtained: if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? a copy of the patient operative report was received with the following information: date of op: (b)(6) 2020, anesthesia: general, postoperative diagnosis: small bowel obstruction.Procedures performed: exploratory laparotomy, lysis of adhesions, placement of vicryl mesh.Procedure: the patient was brought to the operating room and placed on the operating room table in the supine position after adequate general anesthesia was induced.The abdomen was prepped and draped in a standard sterile fashion.A foley catheter had been placed prior to prepping and draping, and appropriate timeout was performed by all operating room staff.We started with a mid-line laparotomy incision through the prior incision with a 10-blade scalpel cutting out the previously placed subcuticular stitch.This was done throughout the entirety of the incision and then superiorly above the incision for approximately 2 centimeters.We then carried with blunt dissection down to the fascia which had the pds suturing it closed.This pds was cut, and we did release the fascia.We identified the· retrorectus mesh that had been extremely well incorporated into the muscle.We did identify the superior edge of the mesh.We found the posterior sheath just superior to it, retracted it anteriorly, incised it with a blade and then identified the peritoneum which was also incised.We were able to enter the intraperitoneal cavity with injuring the underlying structures.We then used a heavy scissors to transect the mesh and peritoneum along the length of the previously placed mesh to the inferior portion.We were able to eviscerate the small bowel and did note that there was a strictured area in the mid-small bowel from dense adhesions and interloop adhesions.We lysed these.They were extremely dense.There was a very small serosal tear, but the bowel was thick, and we did not elect to repair this.These were 2 areas of these interloop adhesions which were taken down with the metzenbaum scissors after which we felt that the liquid and gas freely flowed through them and elected not to resect these.We then ran the entire small bowel from the ligament of treitz to the cecum, and there were no other obstructions noted, and the other remaining small bowel appeared fine.We then milked back a bunch of the succus from the small bowel both proximally and distally to make our closing easier.At this point, we irrigated the intraperitoneal cavity with saline and ensured that we had adequate hemostasis.At this point, we closed in multiple layers.We first placed a vicryl mesh anterior to the omentum, but posterior to our anterior abdominal wall to prevent any contact of the prolene mesh to the small bowel.We then closed the posterior sheath with the mesh with 2 running 0 prolene stitches.We then closed the fascia with 2 #1 pds sutures in a running fashion.We then irrigated the wound.We then closed the dermal layer with running 3-0 vicryl.The skin was closed with 3-0 vicryl in a subcuticular fashion.The abdomen was washed.Dermabond and sterile dressings applied.The patient was extubated, brought to the pacu in stable condition.There were no perioperative complications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc., 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.Product complaint # (b)(4).Corrected information: b3, d6a, h6 - health effect - impact code.

• Brand Name: VCL MESH KNIT UD 12INX12IN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10839930
• MDR Text Key: 216394442
• Report Number: 2210968-2020-09029
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031056909
• UDI-Public: 10705031056909
• Combination Product (y/n): N
• PMA/PMN Number: K810428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: VKML
• Device Catalogue Number: VKML
• Device Lot Number: LL7034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR