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

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

Patient Problems Hematoma (1884); Pain (1994); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 08/21/2016

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: j mod med health, january 2017, vol.33, no.2; doi: 10.3969/j.Issn.1009-5519.2017.02.017 please see article attached.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 product (prolene mesh and 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? event related to prolene polypropylene mesh reported via mw # 2210968-2021-02072.

Event Description

It was reported in a journal article with title: contrastive study on common polypropylene mesh and ultrapro hernia system in repair of giant inguinal hernia.The objective of this retrospective study was to compare the merits and disadvantages of common polypropylene mesh and ultrapro hernia system (uhs) in the repair of giant inguinal hernia to provide a basis for selecting the mesh.From january 2007 to february 2016, 78 patients with giant inguinal hernia were included in the study.The patients were divided into two groups: for group a (n=35; mean age 54.9 ± 10.4 years), ordinary polypropylene mesh woven with two single strands of polypropylene (ethicon) was used and for group b (n=43; mean age 52.8 ± 8.4 years), uhs (ethicon) was used.During the procedure in group a, the lichtenstein hernia repair was performed according to the standard operation method: the ordinary polypropylene mesh was placed in front of the transversalis fascia and behind the spermatic cord, with the lower end 2.0 cm beyond the pubic tubercle and fixed on the pubic tubercle aponeurosis, the symphysis tendon, the inguinal ligament and the outer edge of the anterior sheath of the rectus abdominis.The spermatic cord was put through a hole made on the upper part of the patch and the inner ring opening was reconstructed.Tightness was appropriate.The aponeurosis of the external abdominal oblique muscle was intermittently sutured, and the outer ring opening was reconstructed.In group b, the head-neck-shoulder technique was used: the transversalis fascia was cut at the neck and shoulder position to enter the preperitoneal space, and two wet thin gauze strips were used to fill and separate the bogros space, with an extent of about 10 cm behind the medial side of the pubic tubercle and the outer edge of the rectus abdominis, the lateral side reaching the common iliac vein, the upper side 3 cm beyond the arcuate lower edge of the transversus abdominis of the internal oblique muscle, and the lower side to the bony pelvic edge below the cooper¿s ligament.Space.The lower patch of the uhs was placed in the preperitoneal space and flattened as possible, to cover the entire myopectineal orifice.The upper patch was placed on the posterior wall of the inguinal canal.Reported complications for group a included postoperative pain duration of 2.9 ± 1.1 days (n=?); wound infection (n=1); wound and/or scrotal hematoma (n=3); foreign body sensation or chronic pain (n=9); recurrence (n=5).Reported complications for group b included postoperative pain duration of 3.0 ± 1.2 days (n=?); wound infection (n=1); wound and/or scrotal hematoma (n=4); foreign body sensation or chronic pain (n=3); recurrence (n=1).In conclusion, with regard to giant inguinal hernia with weak posterior inguinal wall, obvious transversalis fascia defect and large hernia ring, the authors believe that uhs preperitoneal space repair is particularly suitable, with the advantages of low recurrence rate, and less foreign body sensation and chronic pain, and it is worthy of clinical promotion.

Manufacturer Narrative

Product complaint (b)(4).Date sent to the fda: 4/6/2021.The following information was requested, but unavailable:  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 product (prolene mesh and 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? h3 evaluation: this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Product complaint (b)(4).Date sent to the fda: 4/6/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11429550
• MDR Text Key: 245132114
• Report Number: 2210968-2021-02073
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2021
• Patient Sequence Number: 1