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U.S. Department of Health and Human Services

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

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ETHICON INC. ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number ULTRAHSUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Seroma (2069); Urinary Retention (2119); Impaired Healing (2378); Swelling/ Edema (4577)
Event Date 11/06/2020
Event Type  Injury  
Manufacturer Narrative
(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: visc med 7; doi: 10. 1159/000509895. 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 (ultrapro hernia system) 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? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported in a journal article with title: safety of inguinal hernia repair in the elderly with perioperative continuation of antithrombotic therapy. The aim of this prospective study is to evaluate the safety of an inguinal hernia repair (ihr) under local anesthesia (la) in the elderly with a perioperative continuation of antithrombotic therapy. Between aug 2018 and aug 2019, 120 male patients (mean age of 72. 77 [range 60-89] and mean bmi of 22. 72 kg/m2) underwent elective primary ihr (n
=
53 right inguinal hernia, n
=
51 left inguinal hernia, and n
=
16 bilateral hernia). The patients were divided into two groups: 60 patients also had coexisting cardiovascular diseases for which they were on chronic antithrombotics (at) (namely aspirin, clopidogrel, and warfarin) and were asked to continue a full dose of at perioperatively (antithrombotic group); and 60 other relatively healthy patients comparable for age and gender who had not been on any prior at (control group). The hernia defect was repaired with tension-free implantation of a double-layer polypropylene mesh ultrapro hernia system (uhs) mesh (ethicon). Postoperative complications for the antithrombotic group include bruising (n
=
1), serosanguinous soakage on dressing (n
=
4), wound seroma (n
=
1), delayed wound healing (n
=
2), and inguinoscrotal swelling (n
=
4). Postoperative complications for the control group include serosanguinous soakage on dressing (n
=
2), wound seroma (n
=
1), delayed wound healing (n
=
1), and inguinoscrotal swelling (n
=
2), and urinary retention (n
=
1). All bruising and seromas were treated within a couple of weeks with conservative treatments, such as warm compression and bed rest. No patient required blood transfusion, reoperation, or readmission. A case of urinary retention observed in the control group resolved spontaneously after a few episodes of intermittent urinary catheterization. Out of 6 cases (4 vs. 2 cases, respectively) of inguinoscrotal swelling observed, only 3 cases (2 vs. 1 case, respectively) needed intervention. Anti-inflammatory and analgesic drugs were prescribed, and t pressure bandage was applied. A total of 3 cases of delayed wound healing were observed (2 vs. 1 case, respectively). Bedside wound exploration and packing were done. It healed after a series of regular dressing. No antibiotics were administered. The perioperative continuation of at did not increase the risk of intra- and postoperative hemorrhagic complications following ihr in the elderly. Thus, ihr under local anesthesia seems to be safe and feasible in this setting.
 
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Brand NameULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
Type of DeviceMESH, 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
9082182213
MDR Report Key11382789
MDR Text Key233732419
Report Number2210968-2021-01809
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K071249
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 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberULTRAHSUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
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: 02/25/2021 Patient Sequence Number: 1
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