• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hematoma (1884); Pain (1994); Hernia (2240); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). (b)(4). Adverse events will be submitted via mw# 2210968-2020-08247, mw# 2210968-2020-08248, and mw# 2210968-2020-08249. 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: chin j dig surg, october 2015, vol. 14, no. 10. 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 ethicon products (ultrapro hernia system, ultrapro hernia plug, and prolene 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?.
 
Event Description
It was reported in a journal article with title: clinical efficacies of ambulatory surgery for inguinal hernia in 1,892 patients. This retrospective study aimed to explore the clinical efficacy of ambulatory surgery for inguinal hernia. From november 2009 to june 2015, a total of 1892 patients (n
=
1739 males and n
=
153 females; age range: 35. 1 to 69. 5 years; average age: 52. 3 years) who underwent ambulatory surgery for inguinal hernia were included in the study. Tension-free repair was used on 1874 cases, including 1592 cases on which ultrapro hernia materials (ethicon) were used, 264 cases with ultrapro plug materials (ethicon), 8 cases with prolene hernia materials (ethicon), 6 cases with gore hernia patch, and 4 cases with polypropylene three-dimensional plug; the bassini method was used for 18 patients. Complaints included abdominal distention after satiation (n
=
?) where patient was transferred to the in-patient department and was successfully discharged from hospital after symptomatic treatment. Other complications are edema in the scrotum and inguinal region (n
=
?), and ecchymoma (n
=
?) which all recovered smoothly after symptomatic treatment. During the follow-up period, there were reports of chronic pain (n
=
?) which improved after analgesic and physiotherapy treatment, recurrence of inguinal hernia (n
=
?). In conclusion, ambulatory surgery for inguinal hernia is safe and effective, with the advantages of few complications, high satisfactory rate and low hospital expenses.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROLENE 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)
J-PAC
25 centre road
somersworth NH 03878
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10731034
MDR Text Key213014241
Report Number2210968-2020-08250
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHSUNK
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 Received10/27/2020
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/23/2020 Patient Sequence Number: 1
-
-