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 Seroma (2069); Post Operative Wound Infection (2446)

Event Date 10/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 clarify 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? if so, please specify.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? (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: international journal of surgery open (2020); 27:52-57.Doi: https://doi.Org/10.1016/j.Ijso.2020.10.011.

Event Description

Title: chest wall reconstruction using a titanium plate sandwiched between two prolene meshes for large chest wall tumours: a single-centre case series study.The aim of this retrospective study is to report our clinical experience in treating large chest tumours combined with chest wall reconstruction using a titanium plate sandwiched between two prolene meshes.From november 2015 to may 2020, a total of 15 patients (male=5; female=10; median age=46 years; age range=30-72 years) with large chest wall tumours who underwent tumour resection and chest wall reconstruction were included in the study.Surgery was performed using a prolene mesh (ethicon) placed in the defect to protect the intrathoracic organs and the second prolene mesh was covered in the surface of the titanium mesh.The reported complications included seroma (n=2) which resolves by careful dressing and compression bandaging, wound infection (n=1) where the prothesis was visible on the skin and underwent reoperation for wound closure, covering the titanium on the fifth month, although removal of the titanium became necessary after 9 months (fig.5).In conclusion, the reconstruction of the anterior chest wall using a titanium plate sandwiched between two polypropylene mesh sheets was successfully performed, and favourable outcomes were obtained.However, further studies with a larger population are required to evaluate the safety and efficacy of this procedure.

• 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 ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11712035
• MDR Text Key: 262896544
• Report Number: 2210968-2021-03643
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• 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: 03/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention