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

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

Patient Problems Hematoma (1884); Neuralgia (4413)

Event Date 10/18/2020

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: surgery 2000; 13:191-6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported in a journal article with title: laparoscopic repair of inguinal hernia.Personal experience and literature review.Between september 1997 to june 1999, a total of 72 laparoscopic hernia repairs with tapp technique in 43 patients (41 males and 2 female), with a mean age of 57.3 years (range 29-76 years), were included in the study.All procedures were performed placing prolene mesh (ethicon), fixed along its upper border and on the cooper's ligament.Reported complications included inguinal-scrotal hematoma (n=1) which required surgical drainage, and inguinal crural neuralgia (n=2) that resolved spontaneously within a few weeks.In conclusion, the repair via the laparoscopic route, in particular with the transperitoneal approach, can treat all types of inguinal-crural hernia (direct, indirect, femoral) and, although it is a technically demanding surgery in an anatomically complex area, we believe that, in expert hands and in particular circumstances, the technique is of relatively easy execution and of sufficiently short duration, and above all it can be an effective and safe procedure for the patient.

• Brand Name: PROLENE POLYPROPYLENE MESH 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: 11905435
• MDR Text Key: 266847635
• Report Number: 2210968-2021-05081
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K962530
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• 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: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention