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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 Fistula (1862); Granuloma (1876); Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); Foreign Body In Patient (2687)
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: 10 klinichna khirurhiia. 2009; no. 9. (b)(4).
 
Event Description
Title: rational management of patients after the operation for abdominal hernia using composite allotransplants the objectives of the study was to improve the early and long-term treatment outcome in patients with post-operative abdominal hernia. The results of treatment of 50 patients, to whom anterior abdominal alloplastic hernioplasty was done, using ultrapro light-weighted large-pore composite mesh (ethicon), were analyzed postoperatively pathogenetically substantiated prophylaxis of early and remote complications. The comparative group included 62 patients, to whom anterior abdominal wall alloplasty was performed, using prolene polypropylene mesh (ethicon). In the ultrapro composite mesh group, reported complications included seroma (n-8), infiltrates (n-5), hematoma (n-2), foreign body sensation (n-2), chronic pain in the implantation site (n-4), restriction of anterior abdominal wall mobility (n-3), granuloma of the anterior abdominal wall (n-1), and recurrence of hernia (n-1). In the prolene polypropylene mesh group, reported complications included seroma (n-17), infiltrates (n-7), hematoma (n-3), foreign body sensation (n-8), chronic pain in the implantation site (n-9), restriction of anterior abdominal wall mobility (n-8), skin-prosthetic fistula (n-2), granuloma of the anterior abdominal wall (n-5), and recurrence of hernia (n-3). Alloplasty of the anterior abdominal wall using composite allotransplants with large pores is an effective way of treating patients with postoperative abdominal hernias and improves the long-term results of surgical intervention without increasing the incidence of recurrences. The individualized administration of combined drug therapy, pathogenetically based approaches to post-operative management of patients, magnetic therapy, magnetic-laser effects or low-frequency electrotherapy helped to reduce the incidence of complications after alloplasty of the abdominal wall, and, if they were detected, it helped rapidly eliminate these complications, reduce the duration of rehabilitation period in the patients, improve their life quality.
 
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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 PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8961131
MDR Text Key157525102
Report Number2210968-2019-86545
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUP
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 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
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 Received08/08/2019
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: 09/04/2019 Patient Sequence Number: 1
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