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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, 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 Key8913070
MDR Text Key155043031
Report Number2210968-2019-85863
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPROMESHUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/20/2019 Patient Sequence Number: 1
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