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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSMUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Fever (1858); Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240)
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: rozhl chir. 2002 nov; 81, suppl 1: s27-30. (b)(4).
 
Event Description
It was reported in a journal article with title: "phs mesh ¿ initial experience. " this study aimed to present a new method for tension free inguinal hernioplasty with the use of phs ¿ prolene hernia system ¿ mesh. Between oct 1999 and feb 2002, 88 male patients with median age of 55. 3 years (20 - 90) with 97 primary or recurring inguinal hernias were operated with tension free inguinal plastic operation using prolene hernia system mesh. Folded phs mesh is inserted into the space prepared. The inner round part (underlay patch) is carefully unfolded in the preperitoneal area with a finger so that the defect in the abdominal wall is completely covered. The central portion is positioned in the place of defective internal inguinal anulus and oval upper layer (onlay patch) is positioned longitudinally from within to the base of the inguinal canal. Complications included hematoma in the subcutaneous tissue in the area of the wound and on the scrotum (n
=
12), seroma in the wound (n
=
4), subfebrile fever of 38°c (n
=
9), pain and edema of the testicle (n
=
4) which subsided quickly; and a relapse (n
=
1). In conclusion, phs mesh hernioplasty have very good results in terms of length of morbidity, return to normal physical activity and in terms of recurrence.
 
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Brand NamePROLENE HERNIA SYSTEM 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)
J-PAC
25 centre rd
somersworth NH 03878
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8478705
MDR Text Key140812167
Report Number2210968-2019-79961
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHSMUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
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: 04/03/2019 Patient Sequence Number: 1
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