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

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

Patient Problems Edema (1820); Erythema (1840); Hernia (2240); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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.[(b)(4)].

Event Description

It was reported via journal article: "title: ambulatory inguinal hernia repair with prolene hernia system (phs)" authors: m.Farrakha, v.Shyam, g.A.Bebars, m.Yacoub, k.Bindu, s.Kolli citation: hernia.2006; 10: 2¿6.Doi: 10.1007/s10029-005-0007-9.The study was conducted to evaluate the feasibility and benefits of inguinal hernia repair with prolene hernia system (phs) mesh (ethicon) under local anesthesia as a day surgery procedure in a multinational society of united arab emirates.A total of 154 patients (age range: 18 to 74 years old) fitted the criteria and were included in the study.The hernia repair was performed by the placement of phs mesh.A preperitoneal space was then created behind the transversalis fascia for the placement of the deep layer of the phs mesh.The connecting cylinder of the phs mesh was fixed to the internal ring by one or two prolene sutures (ethicon), and the superficial layer of the phs mesh was spread onto the floor of the inguinal canal using few prolene 2-0 sutures (ethicon).Reported complications included scrotal edema (n-6), mild wound erythema (n-9), wound infection (n-1), and hernia recurrence (n-1) which was re-operated using the same technique.The present study has demonstrated that inguinal hernia repair with phs performed under local anesthesia, on a day-case basis, is safe and feasible procedure.It is associated with minimal postoperative morbidity, acceptable levels of postoperative pain, early mobilization, and reduced costs of hospitalization.

• Brand Name: PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): J-PAC; 25 centre rd; somersworth NH 03878
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8445000
• MDR Text Key: 139596762
• Report Number: 2210968-2019-79614
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/22/2019
• 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
• Patient Outcome(s): Required Intervention