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

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

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Seroma (2069); Hernia (2240); Obstruction/Occlusion (2422); Thromboembolism (2654)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported in a journal article with title: peculiarities of pre-peritoneal hernioplasty in surgical treatment of ventral hernias of lower and median localization.The purpose of this research work is to analyze and substantiate the advantages of the laparoscopic hernioplasty method, its improvement, to improve the results of surgical treatment of hernias of medial and lower localization.In the process of this research, we used a comparison method based on the surgical intervention by tapp and sublay performed on 405 patients.Among the total number of patients, 286 were female and 119 were male.The mean bmi among all patients was 29 t.The laparoscopic technique in the treatment of ventral hernia was introduced in 2012 by ipom and tapp.Ultrapro j & j (usa) was used for hernioplasty.Mesh prosthesis fixation and peritonealization were performed using ethicon securestrap.Reported complications included seroma (n=9), transplant rejection (n=2), thrombophlebitis (n=3), hernia recurrence (n=2), thromboembolism of small branches of the pulmonary artery (n=1) , adhesive intestinal obstruction, necrosis of the navel skin.In conclusion the development and implementation of laparoscopic techniques show significant advantages in comparison with open laparotomy methods.

Manufacturer Narrative

Product complaint # (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 cite: international journal of pharmaceutical research & allied sciences, 2021, 10(3):25-32 , https://doi.Org/10.51847/hlaztf0q1u.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 (securestrap, ultrapro mesh) 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 the ethicon products involved? patient demographics? adverse events associated with ultrapro mesh device reported via mw # 2210968-2022-07851.Adverse events associated with securestrap device reported via mw # 2210968-2022-07852.

• Brand Name: ULTRAPRO MESH 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; robert-koch strasse 1; p.o. box 1409; norderstedt 22841 ; GM 22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15477264
• MDR Text Key: 300566766
• Report Number: 2210968-2022-07851
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UP
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2022
• 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