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 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.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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 11/06/2020.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, 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 PLUG UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10731028
• MDR Text Key: 213019624
• Report Number: 2210968-2020-08249
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention