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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Hernia (2240); Post Operative Wound Infection (2446); 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. 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. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. 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. 2015; 19: 909¿914. Doi: 10. 1007/s10029-015-1360-y (b)(4).

 
Event Description

It was reported via journal article: "title: results of prosthetic mesh repair in the emergency management of the acutely incarcerated and/or strangulated groin hernias: a 10-year study" author: s. S. Bessa ¿ m. R. Abdel-fattah ¿ i. A. Al-sayes ¿ i. T. Korayem title: results of prosthetic mesh repair in the emergency management of the acutely incarcerated and/or strangulated groin hernias: a 10-year study authors: s. S. Bessa, m. R. Abdel-fattah, i. A. Al-sayes, i. T. Korayem citation: hernia. 2015; 19: 909¿914. Doi: 10. 1007/s10029-015-1360-y the aim of this prospective study was to present a 10-year experience with the use of prosthetic mesh repair in the management of the acutely incarcerated and/or strangulated groin hernias. A total of 234 patients (212 male and 22 female patients; age range: 16 to 85 years old; bmi: 25 to 34) with acutely incarcerated and/or strangulated groin hernias were treated by emergency repair of the hernia using a prolene mesh (ethicon). During the surgical procedure for inguinal hernias, a lichtenstein tension-free repair with the use of a prolene mesh (ethicon) was utilized in all patients. For fermoral hernias, an inguinal approach was used in all patients. The resection¿ anastomosis of non-viable bowel was performed in a single layer sero-muscular extra-mucosal manner using interrupted vicryl 3-0 sutures (ethicon). Reported complications included wound infection (n-14) which required appropriate antibiotics guided by culture and sensitivity studies, scrotal hematoma (n-9) which was treated according to standard measures, mesh infection (n-1) which necessitated removal of the mesh, and recurrences (n-2). It was concluded that from the present 10 years study, the use of prosthetic mesh repair in the emergency management of the acutely incarcerated and/or strangulated groin hernias is safe, is not associated with either major systemic or mesh-related complications and is associated with low recurrence rate, and the presence of intestinal ischemia or necrosis and thus the necessity to perform intestinal resection cannot be considered a contraindication for prosthetic mesh 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.-SAN LORENZO PR
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 Key7926847
MDR Text Key122456587
Report Number2210968-2018-76214
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeEG
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 09/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2018
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: 10/02/2018 Patient Sequence Number: 1
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