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

Catalog Number ULTRAPLUGUNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069); Swelling (2091)

Event Date 05/17/2010

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: journal of the japan surgical association 71 (12), 3039-3044, 2010.The following information was requested, but unavailable: were the cases discussed in this article previously reported to ethicon? if yes, please provide complaint reference numbers.Does the surgeon believe that ethicon product ultraplugunk involved caused and/or contributed to the adverse events described in the article? if yes, please provide event details for each patient including: initial procedure date.Procedure name.Specific patient demographics.Where was the procedure performed? event date.Specific medical/surgical intervention.Ethicon product involved; product code and lot number.Patient pre-existing conditions/other relevant patient history/concomitant medications are any devices available for evaluation?.

Event Description

It was reported in a journal article with title: our experience with a use of light weight mesh for inguinal hernia.The authors examined its (mesh plug method using light weight mesh; ethicon ultra proplug or hereinafter referred to as the "l method") usefulness and problems associated with each technique by comparing cases using the l method against the conventional kugel method (hereinafter referred to as the "k method") and the mesh plug method using heavy weight mesh (hereinafter referred to as the "h method"), with the inclusion of a brief overview of the available literature.This comparison study involves 32 cases (31 male and 1 female; average age: 62.3 years; age range: 20 to 82 years) of surgery in which the l method was used to treat inguinal hernia that were performed from april 2009 to december 2009.The targets for comparison were 73 cases (69 male and 4 female; age: 67.3 years; age range: 23-93 years) that used the k method performed from november 2006 to september 2009, and 38 cases (36 male and 2 female; age 64.6 years; age range: 30-95 years) in which surgery was performed using the h method that took place from january 2007 to september 2009.In l method, after the preperitoneal space is manually detached from the deep inguinal ring after high ligation of the hernia, the ultra pro plug (ethicon), which is a lightweight mesh, is then folded in four, grasped with pean forceps, and inserted into the deep inguinal ring.Anchor is positions in the preperitoneal space and deployed.The rim is positioned on top of the transversalis fascia, the outer slit is applied and the spermatic cord is passed through.The rim and transversalis fascia are sutured together with 3-0 absorbable suture thread at 4 points.At this point, 2 needles are pinned to both ends of the slit.The on lay patch is trimmed along the second blue line from the top edge and the spermatic cord is passed through after having positioned the slit on the outside.The tip of the on lay patch and pubic tubercle are sutured and fixed with 2 stiches of 3-0 absorbable suture thread.The lower edge of the patch is sutured to the inguinal ligament, and the upper edge is sutured to the internal oblique muscle membrane with 4 stiches each using 3-0 absorbable suture thread.Reported complications in l method included pain at first examination after discharge (n-16), wound swelling/swelling (n-2), seroma (n-2), and wound infection/infection (n-1).In conclusion, the use of light weight mesh was considered to reduce the frequency of swelling of the surgical wound, seroma formation, induration formation and sharp pain which might occur more than one month after surgery, and improves the postoperative quality of life.

• Brand Name: ULTRAPRO HERNIA PLUG 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 ; 9082183429
• MDR Report Key: 10765664
• MDR Text Key: 214757066
• Report Number: 2210968-2020-08506
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAPLUGUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention