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

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

Patient Problems Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The single complaint was reported with multiple events through a journal article.No specific patient information regarding events has been provided and it is unknown if the events have been previously reported.The manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Reference journal article.[(b)(4)].

Event Description

It was reported in a journal article entitled: comparison of tension-free hernia repair under local anesthesia in adults: comparison of phs and perfix.Author: jee-man you, kwang-man lee and un-jong choi.Citation: journal of the korean surgical society: vol.72, no.1, january 2007.The purpose of this comparative study was to compare the feasibility of phs® and perfix® procedures under local anesthesia, which are commonly used as tension-free herniorrhaphy in adults, and the difference between the two methods.Between march 2003 to february 2006, 107 patients with mean age of 63.8 years (range 24-91 years) who underwent tension-free herniorrhaphy under local anesthesia were included in the study.The meshes were randomly used.The phs group consisted of 63 patients (male n=56 and female n=7) with mean age of 66.1 years and the perfix group have 44 patients (male n=43 and female n=1) with mean age of 60.5 years.The underlay patch of the phs® mesh was inserted into bogros' space and retzius' space and the onlay patch was fixed with 3-0 prolene® to the cervical ligament, internal transverse muscle and transverse abdominal muscle.In the case of the perfix® mesh, the plug was inserted into the internal inguinal ring and fixed with 3-0 prolene®, and the onlay patch was fixed in the same manner as phs®.Complications in the phs group included wound infection (n=1) and chronic pain (n=1).Complication in the perfix group included wound infection (n=1).In conclusion, with tension-free herniorrhaphy using the phs or perfix mesh, local anesthesia was acceptable and securable, regardless of the mesh type used.Among the patients, those at an older age and with a lower bmi were more tolerant to local anesthesia.

• Brand Name: PROLENE HERNIA SYSTEM 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: 8502299
• MDR Text Key: 141566602
• Report Number: 2210968-2019-80242
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2019
• 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