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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 Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119)
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: j ayub med coll abbottabad (2019): 331-335. (b)(4).
 
Event Description
It was reported in a journal article with title: surgical management of male incontinence, with prolene mesh fixing with prolene sutures; a prospective novel study for the treatment of male incontinence at tertiary care hospital. This study aimed to highlight the outcome of surgical treatment in terms of safety, efficacy and cost-effectiveness in the management of urinary incontinence. This prospective experimental study, conducted from july 2012 to august 2016, involves a total of 48 male patients (mean age: 55. 25±12. 29) with urinary incontinence. After the bulbospongiosis muscle and urethra became intact, 3 1/0 prolene sutures (ethicon) were taken through the periosteum on each side. Pyramid shaped piece of prolene mesh (ethicon) approx. , 2cm at top end 3cm at lower end, anchored on each side with prolene suture (ethicon). Tension over urethra was controlled with impeding flow of irrigant. Mesh was tightened until flow stops. Anchoring sutures were tied. Wound was then closed in layers with absorbable suture and catheter was placed for 24 hrs. Reported complication included leakage while bending (n-12), no improvement in symptoms (n-8), perineal pain after surgery (n-12), infection (n-5), urinary retention (n-3), and erosion of sling (n-2). In conclusion, this study predicted that in patients having moderate to severe urinary incontinence, prolene mesh repair anchoring with prolene suture can be an efficient and cost effective treatment for the urinary incontinence with least complications.
 
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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
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9280110
MDR Text Key167888043
Report Number2210968-2019-89524
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodePK
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 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
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 Received10/08/2019
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: 11/05/2019 Patient Sequence Number: 1
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