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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 Unspecified Infection (1930); Hernia (2240); Post Operative Wound Infection (2446); Pulmonary Hypertension (4460); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2019
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: qin et al. Journal of cardiothoracic surgery (2019) 14:118; doi: https://doi. Org/10. 1186/s13019-019-0938-3. 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 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 product 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: a comparative study of thoracoscopic and open surgery of congenital diaphragmatic hernia in neonates. This retrospective study discussed about a comparative study of thoracoscopic and open surgery of congenital diaphragmatic hernia in neonates. From 2015 to 2018, a total of 70 children with congenital diaphragmatic hernia (cdh) were enrolled in the study. The patients were divided into two groups: 26 cases (male=10, female=16; mean age= 15. 3 ± 2. 1 day) received thoracoscopic-assisted diaphragmatic hernia repair (observation group) and 44 cases (male=19, female=25; mean age=14. 7 ± 2. 8) received open diaphragmatic hernia repair (control group). In observation group, during procedure, the hernia contents were repositioned to the abdominal cavity, and the diaphragm defect was fully exposed in order to observe the size of the diaphragm defect. If there is a hernia sac in the child, push it to the abdominal side, and then use 2¿0 non-absorbable needle suture to suture the defect diaphragm intermittently. The patch uses a new type of lightweight ultrapro hernia system (uhs) device (ethicon) to suture the defect from both sides of the small tension to the middle. After suturing, the operating instruments were pulled out and the incision was sutured. Reported complications included pulmonary infection (n=3); incision infection (n=2); pulmonary hypertension (n=3); scleredema (n=1); recurrence (n=3). In conclusion, the intraoperative hemodynamic parameters of cdh repair under thoracoscopy were more stable, the duration of postoperative mechanical ventilation, antibiotic use and hospitalization were shortened, and the therapeutic effect was better.

 
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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 Key11355899
MDR Text Key232838575
Report Number2210968-2021-01618
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK071249
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 01/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULTRAHSUNK
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 Received02/24/2021
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: 02/20/2021 Patient Sequence Number: 1
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