MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC

Catalog Number PMM3

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

Patient Problems Foreign Body Reaction (1868); Fluid Discharge (2686); Peripheral Edema (4578)

Event Date 10/29/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a tension-free repair of right inguinal hernia under spinal anesthesia on (b)(6) 2021 and the mesh was implanted. It was reported that twenty days after the surgery, the patient experienced wound secretion. Considering the rejection of the patch, right scrotal edema removal was performed. Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Component code: (b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. 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. The patient demographic info: weight, bmi at the time of index procedure what are the patient comorbidities/concomitant medications? was any deficiency or anomaly of the mesh? if yes, please describe it. Does the patient have known allergic history to medical device, food or medications? was the device removed? if so, please date and details of the re-operation. What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

• Brand Name: PROLENE MESH 15X15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13006324
• MDR Text Key: 286466859
• Report Number: 2210968-2021-12607
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: PMM3
• Device Lot Number: PPBDKM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/14/2021 Patient Sequence Number: 1