MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE; MESH, SURGICAL, POLYMERIC

Model Number PPL1515

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

Patient Problems Pain (1994); Swelling (2091); Post Operative Wound Infection (2446); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, after oblique inguinal hernia operation, the patient suffered in wound fester infection.Two days after discharge, swelling of the incision and scrotum was found with pain, local flushing and gradually worsening.The patient was re-hospitalize.A hard mass was found from the lower end of the incision to the scrotum.The puncture extracted the pink turbid exudate.The diagnosis was right inguinal indirect hernia repair after infection, with anti - infection treatment.Local skin flushing and tenderness subsided, but the mass did not shrink significantly.Mr examination revealed soft tissue infection of the wound in the right inguinal region with abscess formation.The strong liquid was extracted the next morning and anti-infection treatment was continued.

• Brand Name: PARIETENE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9485167
• MDR Text Key: 177173735
• Report Number: 9615742-2019-03870
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: PPL1515
• Device Catalogue Number: PPL1515
• Device Lot Number: STA2251X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Date Device Manufactured: 01/29/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR