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

Catalog Number PROMESHUNK

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

Patient Problems Cyst(s) (1800); Swelling (2091); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event described in article for (b)(6) year old male is submitted via mw# 2210968-2019-85862.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: hernia (2012) 16:589¿591; doi 10.1007/s10029-011-0786-0.(b)(4).

Event Description

It was reported in a journal article with title: first cases of giant pseudocyst complicating inguinal hernia repair.This study aimed to present two cases of giant pseudocyst complicating inguinal hernia repair and describe its management and clinical course.A (b)(6) year old male and a (b)(6) year old male underwent lichtenstein hernioplasty with polypropylene (prolene) mesh for left direct inguinal hernia.At 5 and 7 months after surgery, respectively, they developed an asymptomatic swelling at the site of the scar that increased over a period of months.Ultrasound and ct scan revealed the presence of a cyst with liquid content with no visible recurrence.Both patients underwent periodic aspiration of the cyst in another center, with refilling of it within 3¿5 days; liquid was clear.At 6 and 10 months after surgery, respectively, the size of the pseudocysts were 10 x 6 and 11 x 5 cm, respectively.Both patients underwent surgery in which intraoperative findings a huge capsule that, when opened, was formed by multiple trabeculation and filled with a clear liquid.Some soft amorphous white-yellowish material was also found.Aspiration of residual liquid was performed, and a blake drain was left in both patients.During the 1st post operatory week, the average volume of liquid drained per day was almost 250 cm3 in both patients.The 2nd week it decreased to 50 cm3; the drains were removed in the 3rd week in both patients.At 6 and 10 months of follow up, respectively, no recurrence was found in either patient.The etiology and pathogenesis of the pseudocyst formation remain uncertain, and its incidence has not yet been well documented.Some authors support the hypothesis that pseudocyst could be secondary to seroma formation, or a hematoma that later matured into a cyst.As described previously, it appears that mesh is strongly associated with the development of the pseudocyst.

• Brand Name: PROLENE POLYPROPYLENE 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): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8913070
• MDR Text Key: 155043031
• Report Number: 2210968-2019-85863
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• 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: 07/26/2019

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
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/20/2019
• 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
• Patient Age: 61 YR