MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO COMFORT PLUG UNKNOWN; MESH, SURGICAL, POLYMERIC

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).

• Brand Name: ULTRAPRO COMFORT PLUG UNKNOWN
• Type of Device: MESH, 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 Key: 8280386
• MDR Text Key: 134183934
• Report Number: 2210968-2019-78588
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K070224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Other
• 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 Received: 01/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UCPUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention