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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hematoma (1884); Seroma (2069); Urinary Tract Infection (2120)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: hernia. 2014; 18: 193 198. Doi: 10. 1007/s10029-013-1211-7. (b)(4).
 
Event Description
It was reported via journal article: "title: lichtenstein technique for inguinal hernia repair using polypropylene mesh fixed with sutures vs. Self-fixating polypropylene mesh: a prospective randomized comparative study" authors: g. Chatzimavroudis, b. Papaziogas, i. Koutelidakis, i. Galanis, s. Atmatzidis, p. Christopoulos, t. Doulias, k. Atmatzidis, j. Makris. Citation: hernia. 2014; 18: 193 198. Doi: 10. 1007/s10029-013-1211-7. The aim of this prospective randomized study was to evaluate the effect of a relatively new mesh with self-fixating properties, used to repair inguinal hernia with the lichtenstein technique, on early and chronic post-operative pain. Between june 2009 and june 2010, a total of 50 patients (48 males and 2 females; mean age of 60. 5 ± 17. 3 years) with primary unilateral inguinal hernia were treated using the lichtenstein technique. Patients were randomly assigned to receive either a polypropylene mesh, fixed with polypropylene sutures (n- 25; group a), or a self-fixating polypropylene mesh with resorbable polylactic acid microgrips (n-25; group b). During the surgical procedure in group a, the traditional lichtenstein technique was performed using a heavy-weight prolene polypropylene mesh which was trimmed according to each patient¿s inguinal floor size, with special attention to overlap the pubic tubercle by 2 cm medially. The mesh was secured in place with prolene 2-0 sutures. In group b, 1 prolene 2-0 suture was placed superficially to the pubic tubercle to prevent mesh dislocation. In group a, reported complications included seroma (n-7) and hematoma (n-4). In group b, reported complications included seroma (n-10) and hematoma (n-3). In all patients with seroma or hematoma, the fluid collection had been completely absorbed at the 3-month follow-up. It was concluded that the self-fixating mesh can be safely and effectively used for inguinal hernia repair.
 
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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.
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 Key7613263
MDR Text Key111460316
Report Number2210968-2018-73551
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,literature
Reporter Occupation
Type of Report Initial
Report Date 05/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/19/2018 Patient Sequence Number: 1
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