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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930); 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. No specific patient information regarding events has been provided. Attempts are being made to obtain the following information. If further details are received at the 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: ambulatory surgery. 2014; 20(3) please see referenced article attached. (b)(4).
 
Event Description
Journal article title ¿experience in day surgery with prolene hernia system (phs): the aim of this study was to evaluate the outcomes of inguinal hernia repair with prolene hernia system (phs) mesh under local anesthesia with sedation as a day surgery procedure within a surgical training program. The authors presented a retrospective study of 1840 patients (147 women and 1693 men) treated in our ambulatory unit of both primary and recurrent inguinal hernia repair using 3d mesh from 1997 to 2005. During the surgical procedure, phs was used for all repairs. In both direct and indirect hernia repair, the hernia sac was dissected and reduced into the abdominal cavity. A preperitoneal space was then created behind the transversalis fascia for the placement of the deep layer of the phs mesh. A critical step of the phs mesh technique was the fixation of the superficial onlay layer to the pubis by prolene 2-0 suture with a maximum of 4 further sutures fixed at the cardinal points of the inguinal ligament and the conjoined tendon. Care was taken to avoid entrapping nerves in the stitches. Reported complications included pain, hematoma, seroma, and infection (n-6); and chronic pain or hernia recurrence (n-4). It was concluded that inguinal hernia repair using the phs technique under local anesthesia with sedation is feasible on a day case basis with a safe and reliable procedure with low rates of complication, recurrence, and late symptoms in both early and long-term follow-up.
 
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Brand NamePROLENE HERNIA SYSTEM UNKNOWN PRODUCT
Type of DeviceMESH
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 Key7639653
MDR Text Key112429521
Report Number2210968-2018-73854
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K984220
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 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
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 Received05/31/2018
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: 06/26/2018 Patient Sequence Number: 1
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