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); Seroma (2069); Urinary Retention (2119); Hernia (2240); Unspecified Tissue Injury (4559)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 inc, 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.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-07186, 2210968-2022-07187.Citation: chinese journal of hernia and abdominal wall surg (electronic edition), april 2018, vol.12, no.2.

Event Description

Title: clinical effect of open anterior repair of femoral hernia.This retrospective study aims to analyze the cases of femoral hernia admitted to ganzhou people's hospital from may 2014 to december 2016 and compared the clinical data of 13 cases of elective surgery and 27 cases of emergency surgery.40 patients, including 14 males and 26 females, were divided into elective emergency group according to the urgency of surgical treatment, including 13 patients in elective group, aged 17 years to eighty-one years old, with an average of (47.3 ± 16.4) years, 27 patients in the emergency group, aged 39 years to 89 years, with an average of (62.8 ± 16.1) years.The patch used is manufactured by johnson & johnson ultraprotm hernia system (uhs) patch device and well-released d10 patch produced by beijing tianzhu changyun medical technology co., ltd., the sutures are ethicon absorbable suture and prolene non-absorbable suture produced by johnson & johnson.All patients were treated with conventional open repair.Elective cases in this group 13 cases and emergency group 13 had preperitoneal repair with either a uhs patch or a d10 patch.Mcvay's repair was used in the remaining 14 emergency cases.Preperitoneal placement of patches without tension repair was performed in patients undergoing elective surgery, in those with impacted bowel and omentum that were not necrotic and with clear fluid in the hernia sac in the emergency department.Before sufficient mobilization of the peritoneum, the patch must cover the entire musculopubic foramen to secure the patch with absorbable sutures.Mcvay tissue suture repair was performed for intestinal and omental necrosis and local infection of fluid opacification in the hernia sac, and non-absorbable prolene suture was used for repair and suture.Finally, the absorbable suture was used to suture the subcutaneous tissue and skin in turn.All patients were followed up in the outpatient department 1 month after discharge, and telephone follow-up once in the next 6 months.Reported complications included: (n=4) hematoma.(n=5) seroma.(n=1) bladder injury.(n=4) urinary retention.(n=9) early wound pain, which were improved after symptomatic treatment (n=4) wound infection, all of them were superficial infections, which were cured by dressing change.(n=1) recurrence.It was concluded, that open preperitoneal tension-free patch herniorrhaphy is a safe and alternative surgical method for the treatment of elective femoral hernia and some emergency femoral hernias; however, the early complications of emergency surgery are more than those of elective surgery, and it is recommended to perform surgical treatment of femoral hernia in the elective state as far as possible.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 09/02/2022.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.Additional information was requested and the following was obtained: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article?--no.Which specific ethicon products have been used during the procedures (product code, lot number)? unk.Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.No.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? no.Product complaint # (b)(4).Date sent to the fda: 09/02/2022.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.H1: additional information was received that this device was not involved in the event.Therefore, this medwatch report will be voided.

• Brand Name: ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15334811
• MDR Text Key: 299051450
• Report Number: 2210968-2022-07184
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention