MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number ULTRAPROMUNK

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Tissue Damage (2104); Blood Loss (2597); Not Applicable (3189)

Event Date 06/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Adverse events will be submitted via mw# 2210968-2020-08575, and mw# 2210968-2020-08577, and 2210968-2020-08578.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: ann transl med 2019;7(22):698 doi: | http://dx.Doi.Org/10.21037/atm.2019.10.82.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (prolene suture, monocryl, suture, prolene mesh, ultrapro mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved?.

Event Description

It was reported in a journal article with title: mesh-preservation approach to treatment of mesh infection after large incisional ventral hernia repair¿how i do it.This study presents a case of a (b)(6) year old male who suffered from sigmoid colon perforation due to blunt abdominal injury and underwent exploratory laparotomy with sigmoid colostomy performed 3 years ago, which was complicated by surgical site infection and an incisional hernia over the right lower quadrant was detected.Ultraprotm, monocryltm or prolenetm (ethicon) mesh was trimmed into positioned on the surface of the hernia sac.The mesh was flattened, and the defect was closed by suture before mesh fixation using 2/0 prolene suture (ethicon).On the post-operative day 17 outpatient follow-up, the incision healed well, the color of skin around the incision became hyper-pigmented (n=1).On postoperative day 23, the patient complained about pain over the operative site (n=1), and exudate from the incision (n=1).With the amount of exudate increased, a subcutaneous cavity was formed, and ultrasonic examination showed a limited liquid anechoic zone, with clean boundary, measuring 9.4 cm × 4.6 cm × 11.4 cm within the subcutaneous soft tissue in the surgical site.Surgical debridement and drainage were performed under general anesthesia on postoperative day 40, which found that there was about 80 ml of dark red jelly like necrotic tissue and old clots (n=1) accumulated beneath the mesh.The mesh was preserved.Moderate amount of coagulase-negative staphylococci and propionibacterium was found on the effusion (n=1).On the 8th day, granulation tissue adherent with the mesh was observed on the wound surface, size of the incision was gradually reduced, and the mesh could be seen on the wound surface.On postoperative day 11, no bacterial growth was observed.The wound was cleaned with normal saline daily and was covered with sterile dressing.Size of the incision gradually reduced, the mesh was covered by skin and the incision completely healed by postoperative.On 22 months of follow-up after hernia repair, the wound completely headed with no pain and no recurrence of incisional hernia.When mesh infection is detected, thorough debridement should be carried out as early as possible and endeavour to obtain the sterility of the mesh surface, and vacuum sealing drainage should be applied to assist the mesh-preserved healing process, protecting the patient from further damage.There are few comprehensive studies on mesh-preserving treatment of mesh infection after large incisional hernia repair, which is completely feasible from our experience, and more clinical trials with larger sample size are needed for further verification of our conclusion.In the meantime, there is a vast space for innovation in specific treatment methods such as infection control, wound cleaning and promoting tissue healing.

• Brand Name: ULTRAPRO MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10775278
• MDR Text Key: 214770569
• Report Number: 2210968-2020-08576
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAPROMUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR