• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

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.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
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
MDR Report Key10775278
MDR Text Key214770569
Report Number2210968-2020-08576
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberULTRAPROMUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2020 Patient Sequence Number: 1