MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 1INX4IN; MESH, SURGICAL, POLYMERIC

Model Number SPMXS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2004 and prolene was implanted.It was reported that she experienced undisclosed injuries.It was reported that patient underwent concurrent vaginal hysterectomy procedure.No additional information was provided.

Manufacturer Narrative

This emdr represents supplemental report # 2210968-2017-33032 for previously submitted mdr number 2210968-2017-70668, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: PROLENE SOFT MESH 1INX4IN
• 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; 00754 PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan 08869
• MDR Report Key: 12874216
• MDR Text Key: 281270198
• Report Number: 2210968-2021-12075
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031050501
• UDI-Public: 10705031050501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SPMXS
• Device Catalogue Number: SPMXS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• 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
• Patient Age: 51 YR
• Patient Sex: Female