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

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 09/10/2021

Event Type  Injury  

Event Description

It was reported in a journal article with title: a novel technique for thyroplasty type 1, with prolene mesh implant.The objective of this study is to analyze the efficacy of a modified approach to thyroplasty type one using prolene mesh implant.The study was conducted at tertiary care and teaching combined military hospital kharian from july 2020 to jan 2021.Patients of age 15 years onwards and with vocal cord paralysis / paresis due to multiple causes were included in the study.There were 23 females (38.5%) and 15 male (61.50%) patients.26 patients (66.67%) had unilateral vocal cord dysfunction while 13 (33.33%) had bilateral dysfunction.Ethicon prolene mesh 6 x 6 cm was used to make a swiss roll, secured with prolene 2/0 suture (ethicon).Reported complication included one patient suffered a subcutaneous hematoma with a skin infection.In conclusion these results were comparable to many other studies for vocal cord medialization with different implant materials.But prolene mesh implant offers an easily available yet cost-effective alternative with similar benefits.

Manufacturer Narrative

(b)(4).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? 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).Device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-00805 and.Citation: https://doi.Org/10.1016/j.Jvoice.2021.09.015.

• Brand Name: PROLENE POLYPROPYLENE 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.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13560218
• MDR Text Key: 285937346
• Report Number: 2210968-2022-01177
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K962530
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1