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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). 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.   the single complaint was reported with multiple events. There are no additional details regarding the additional events.   citation: journal of laparoendoscopic & advanced surgical techniques (2020); doi: 10. 1089/lap. 2020. 0878.   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 the ethicon products 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? patient demographics? adverse events associated with the proceed mesh device reported via mw # 2210968-2021-06193. Adverse events associated with the prolene blue suture reported via mw # 2210968-2021-06195. Adverse events associated with the ethilon black suture reported via mw # 2210968-2021-06196. Adverse events associated with the ethilon black suture for the specified male patient reported via mw # 2210968-2021-06197. Adverse events associated with the prolene blue suture for the specified male patient reported via mw # 2210968-2021-06198. Adverse events associated with the physiomesh device for the specified male patient reported via mw # 2210968-2021-06199. Adverse events associated with the proceed mesh device for the specified male patient reported via mw # 2210968-2021-06200.
Event Description
It was reported in a journal article with title: quality of life using the carolinas comfort scale for laparoscopic incisional hernia repair: a 12-year experience in a retrospective observational study. The primary aim of this prospectively collected date of a retrospective observational study was to assess the impact of lihr on patient satisfaction and the impact on qol. Secondary aims included describing the standardized technique used throughout a 12-year experience of a single surgeon at a large district general hospital, the intraoperative details and other postoperative surgical outcomes such as los in hospital, complications, and functional recovery, including return to work and normal daily activities. Between 2007 to 2019, a total of 97 patients (34 male and 63 female; median age
57 years; bmi
32 kg/m2) who underwent a primary or repeated elective laparoscopic incisional hernia repair (lihr) were included in the study. Surgery was performed by using a composite mesh [proceed (ethicon), physiomesh (ethicon), or competitor]. The mesh is sized adequately and 2-0 polypropylene sutures [2-0 prolene (ethicon)] are placed at each of the poles (fig. 3). The edges of the hernial defect are approximated using transfascial 1 nylon extracorporeal sutures [ethilon (ethicon)], which are introduced through stab incisions using an endoscopic suturing device. These are passed 1 cm from the hernial defect edge and at 2¿2. 5 cm intervals (fig. 4). This does not apply to hernia repairs related to pfannenstiel incisions, where the defect closure is not feasible. The 2-0 polypropylene sutures on the mesh are transfascially fixed to the abdominal wall with the use of the endoscopic suturing device. The median follow-up period for patients was 42 months, ranging from 2 to 140 months. Reported complications included a male patient (n
1) had small bowel obstruction which required a laparotomy during which the mesh was removed. He was discharged from hospital 12 days after the initial operation; iatrogenic bowel injuries (n
2) which occur intraoperatively, one was repaired primarily and one required bowel resection with a primary anastomosis; recurrence of incisional hernia (n
1); wound infection (n
1); seroma (n
9) requiring radiological drainage in 2 patients while 7 patients were managed conservatively; hematoma (n
3) requiring a laparoscopic washout in 1 patient while 2 were managed conservatively; pain after surgery (n
6) where 2 patients reattended the hospital with severe acute pain but recovered subsequently, while 4 developed chronic pain; a total ccs scores between 11 and 60 indicating moderate discomfort (n
12); a total ccs score higher than 90 indicating debilitating discomfort (n
1); poor patient satisfaction (n
1); very poor patient satisfaction (n
3). In conclusion, the technique for lihr displayed in this study is safe and effective. There was an acceptable rate of complications, with a low recurrence rate. Patients were highly satisfied and had a good qol after the procedure.
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Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12147938
MDR Text Key262671060
Report Number2210968-2021-06194
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2021
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: 07/09/2021 Patient Sequence Number: 1