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 Problem Post Operative Wound Infection (2446)

Event Date 01/01/2008

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.  the single complaint was reported with multiple events.There are no additional details regarding the additional events. citation: not reported.Event related to patient in case 1 reported via mw # 2210968-2021-03431.Event related to patient in case 3 reported via mw # 2210968-2021-03433.Event related to patient in case 4 reported via mw # 2210968-2021-03434.Event related to patient in case 5 reported via mw # 2210968-2021-03435.Event related to patient in case 6 reported via mw # 2210968-2021-03436.Event related to patient in case 7 reported via mw # 2210968-2021-03437.

Event Description

It was reported in a journal article with title: wound infections and mesh infection following inguinal hernia surgery.The objective of this study is to present the outcome of wound infection and mesh infection following the inguinal hernia surgery using a prolene hernia system (phs) ethicon or prolene 3d patch (3dp) (ethicon) and mesh plug (ethicon).The author¿s observed wound infection from 2 to 7 weeks following surgery in 4 cases (0.5% incidence).No mesh removal, infection or hernia recurrence and mesh resection surgeries were performed.Mesh infection was observed in 3 patients after inguinal hernia surgery that was performed at another hospital.Case 1- (b)(6) years old male incidence of infections during week 2 and week 7 following surgery.Case 2 ¿ (b)(6) years old male incidence of infections during week 2 and week 7 following surgery.Case 3 ¿ (b)(6) years old male incurred after bleeding on the day of surgery which was resolved by applying pressure, but a surgical hematoma formed on the following morning.Part of the wound self-collapsed on day 10 following surgery, so we punctured it.An infection also occurred 2 weeks after the surgery.Case 4 ¿ (b)(6) years old male incurred cellulitis along the entire length of the wound occurred in the third week following surgery.Inflammatory microbe (staphylococcus aureus.) , slight fluid retention was observed with elevated fat concentration in the preperitoneal cavity and the inguinal canal subcutaneously under the right inguinal region.All 4 cases recovered in 1 to 6 weeks without having to resect the mesh.None of the cases experienced reoccurrence of infection or hernias.Case 5 ¿ (b)(6) years old male underwent a mesh resection surgery 6 months after the onset of infection because the infection onset in the second month following phs for an internal inguinal ring hernia and the fistula persisted even after incision and drainage was performed.Case 6 ¿ (b)(6) years old male 2 months after phs repair for right internal inguinal hernia.Formation of chronic fistula , inflammatory microbes (staphylococcus aureus ), abscess was observed in the inguinal canal and preperitoneal cavity.Case 7 ¿ (b)(6) years old male initial onset of delayed wound infection 5 years following mesh plug (ethicon) surgery for right external inguinal hernia.Thereafter, fistula formation repeatedly reoccurred.The fistula was closed, but the patient made a visit due to abscess formation.Redness, swelling, and tenderness at the right inguinal region was observed.Mri: light t2-weighted image was performed abscess was suspected due to part of the preperitoneal cavity and subcutaneous area in the right inguinal region exhibited high signals at the sites where the plugs were positioned.Pus excretion from the preperitoneal cavity via the internal inguinal ring following removal of an abscess in the inguinal was observed.There was no onset of infection recurrence, hernia recurrence, or chronic pain in any of the patients 18 months, 18 months, and 24 months after recovery, respectively.

• Brand Name: PROLENE HERNIA SYSTEM 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 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11676757
• MDR Text Key: 261732341
• Report Number: 2210968-2021-03432
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K984220
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• 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: 03/19/2021
• 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
• Patient Age: 37 YR