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

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.

• Brand Name: ULTRAPRO HERNIA SYSTEM 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 ; 9082182213
• MDR Report Key: 11382789
• MDR Text Key: 233732419
• Report Number: 2210968-2021-01809
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• 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 Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: ULTRAHSUNK
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/26/2021
• 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