MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, 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 Key: 9280110
• MDR Text Key: 167888043
• Report Number: 2210968-2019-89524
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention