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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 Hematoma (1884); Unspecified Infection (1930); Swelling (2091); Burning Sensation (2146); Hernia (2240); Urinary Frequency (2275); Not Applicable (3189)
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: world j surg (2007) 31:1751¿1757; doi 10. 1007/s00268-007-9090-7. (b)(4).
 
Event Description
It was reported in a journal article with title: pain after open preperitoneal repair versus lichtenstein repair: a randomized trial. The purpose of this trial was to compare an open preperitoneal to an open anterior approach in terms of chronic pain, as such a study has not been reported before. Between dec2004 and sep2005, 172 patients with primary unilateral inguinal hernia were randomly underwent either open preperitoneal kugel (n
=
86; n
=
85 male and n
=
1 female; mean age of 55. 6 years [sd15. 8]; mean bmi of 25. 1 kg/m2 [sd2. 9])or the standard open anterior lichtenstein procedure (n
=
86; n
=
85 male and n
=
1 female; mean age of 54. 4 years [sd13. 6]; mean bmi of 25. 4 kg/m2 [sd2. 7]). In lichtenstein procedure, a 6x11 cm prolene mesh was trimmed to fit the inguinal floor, as necessary. The mesh was sutured to the ligament of poupart with a non-absorbable suture and secured cranially using an absorbable suture. In lichtenstein procedure, complications included hematoma (n
=
14), infection (n
=
5), dysejaculation (n
=
1), swelling/bulging (n
=
12) and urinary frequency (n
=
1) which ct scan showed mesh on the bladder, treated with removal of the preperitoneal mesh resolved the problem and definitive hernia repair was planned. Two recurrences were recorded treated with reoperation (n
=
? unspecified per group). This recurrences were regarded as technical failure. The level of experience of the supervising surgeon was not specified, and it is therefore possible that a procedure carried out under less experienced supervision might have failed, thereby contributing to the recurrence rate. The kugel procedure is a feasible alternative for the standard lichtenstein procedure and is associated with less chronic pain at three months. Most likely the neuropathic pain and numbness with the lichtenstein technique are results of more nerves at risk with the anterior approach.
 
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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 Key8931904
MDR Text Key156433361
Report Number2210968-2019-86171
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeNL
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 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2019
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 Received07/31/2019
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: 08/26/2019 Patient Sequence Number: 1
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