• 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. ULTRAPRO COMFORT PLUG UNKNOWN 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. ULTRAPRO COMFORT PLUG UNKNOWN MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UCPUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Impaired Healing (2378); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative

(b)(4). This report is related to a study; 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. Investigator initiated study - (b)(6) final study report ((b)(6) hernia registry).

 
Event Description

It was reported in investigator initiated study ¿quality assurance inguinal hernia. ¿. All surgery date up to december 31, 2016 and follow-up date up to december 31, 2017. All 12818 patients from 48 centres participated in this study: left inguinal hernia ¿ total 5610 (male 87. 7% and female 12. 3%), right inguinal hernia ¿ 6914 ( male 86. 9% and female 13. 1%), left and right inguinal hernia ¿ total 294 ( male 89. 8% and female 10. 2%); age category from 12+ to 80+. This resulted in a total number of 13112 procedures: ethicon product - 3869 surgeries with upp (ultrapro plug) , 9146 with uhs ( ultrapro hernia system) and 69 with ucp (ultrapro comfort plug); other ¿ 21. Subsequently, only patients who have a completed follow-up by doctor both after 4 weeks and after 12 weeks and with whom the carolinas comfort scale could be determined are used : total 5062 male and 726 female with left, right or both inguinal hernia. Age category from 12+ to 80+. In total, there are 5788 patients in the complete cases population. Of these, 164 had surgery on both sides. Thus, there are 5952 procedures: ethicon product - 1710 surgeries with upp (ultrapro plug) , 4201 with uhs ( ultrapro hernia system) and 27 with ucp (ultrapro comfort plug); other ¿ 9. Total 201 procedures (1. 5% of 13112 ) had post-operative complications such as: seroma (57), infection (7), non-healing wound (19), secondary haemorrhage (50) and hematoma (84). Pain ( 4 weeks follow-up ¿ n=1482; 12 week follow-up ¿ n=1049) testicular pain ( 4 weeks follow-up ¿ n=216; 12 week follow-up ¿ n=77; 52 week- n=30) inguinal pain (4 weeks follow-up ¿ n=523; 12 week follow-up ¿ n=281; 52 week- n=167) number of patients with relapse at follow-up examination (across all visits)- n= 97 hematoma/seroma (4 weeks follow-up ¿ n=354; 12 week follow-up ¿ n=26). Wound infection ( 4 weeks follow-up ¿ n=53; 12 week follow-up ¿ n=0).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAPRO COMFORT PLUG UNKNOWN
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt
GM
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8280386
MDR Text Key134183934
Report Number2210968-2019-78588
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK070224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,STUDY
Reporter Occupation
Type of Report Initial
Report Date 01/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUCPUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
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: 01/27/2019 Patient Sequence Number: 1
-
-