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U.S. Department of Health and Human Services

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

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ETHICON INC. ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Seroma (2069); Post Operative Wound Infection (2446)
Event Date 03/03/2020
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 of article: rev hispanoam hernia. 2020;8(3):125-130 http://dx. Doi. Org/10. 20960/rhh. 00294. 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 product (ultrapro hernia plug) 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 product involved? patient demographics.
 
Event Description
It was reported in a journal article with title: ventral hernia of small diameter: abundant and disregarded. The objective of this study is to analyze the long and short term results in patients operated on for small-diameter ventral hernia to quantify the number of local complications and recurrences in a series of patients. The aim is to contribute to the search for a feasible low morbidity repair technique in an as (ambulatory surgery) program to minimize the negative impact on the patient's life, with a low recurrence rate and effective cost. From january 2013 to december 2017, 850 patients who met the inclusion criteria were operated on. The mean age was 49. 27 years and the mean bmi was 27. 50 kg/m2. From 2013 to 2016, 71 patients (7. 6%) with a bmi greater than 35 were operated on. The mean size of the defect was 1. 6 cm, with a minimum of 0. 5 and a maximum of 5 cm. Repairs were made with suture in smaller holes and with prosthetic mesh in larger ones. The simple suture was made with non-absorbable material and in an interrupted manner. When the flat mesh was used, it was preferably placed in the preperitoneal space, exceeding the edges of the defect by more than 2 cm and fixed with transfascial loose stitches of absorbable material. The defect was closed over the mesh if this was possible without tension. An ultrapro plug (ethicon®, united states) three-dimensional mesh device was also used, which was placed in the preperitoneal and suprafascial space, fixed with absorbable material. Finally, the wound was closed with navel reconstruction if necessary. Reported complications included seroma (n
=
29), hematoma (n
=
16), wound infection (n
=
35) of these, 26 were before the prophylactic dose of antibiotic was given. None of these wound infections required removal of the prosthesis for healing. Infection (n
=
10) patients without a prosthesis and in (n
=
25) with a prosthesis moderate-severe pain (n
=
8), skin necrosis (n
=
1)and reoperation due to bleeding (n
=
1). In conclusion simple suture may be an option for patients with defects smaller than 1 cm in diameter. In larger holes, the use of prostheses in the preperitoneal space is a good choice without increasing morbidity with a low recurrence rate.
 
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Brand NameULTRAPRO HERNIA PLUG UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
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 Key11905491
MDR Text Key266738487
Report Number2210968-2021-05082
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K070224
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 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
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: 05/28/2021 Patient Sequence Number: 1
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