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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 adverse events described in the article? if yes, provide details of event and specific suture product code.Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: date and type of procedure, where procedure was performed, specific medical/surgical intervention per patient, product involved, pre-existing conditions.Are the product code and lot numbers available for ethicon devices used?.

Event Description

It was reported in journal article ¿use of three types of synthetic mesh material in sling surgery: a prospective randomized clinical trial evaluating effectivenes and complications¿ that patients with stress incontinence underwent sling surgery and mesh was implanted in group 2.The aim of this study was to determine the surgical success and complication rates of mixed type of mesh materials in sling surgery over a 4-year follow-up period between 2005 and 2007.In the operative technique, an incision with an inverted ¿a¿ shape was made on the anterior wall of the vagina.The upper part of the a-shaped incision was formed into an island belonging to the vaginal wall.Mesh was sutured onto the upper part of the a on the vaginal island with absorbable suture.Mesh was fixed on both the right and left sides of the island in a helical manner to form a suspension, and using curved kishner needles, the sutures were transferred to the suprapubic area.After confirmation that the bladder and urethra were normal, the suture was ligated crosswise in the suprapubic region.Postoperative complications included vaginal erosion, incontinence, urine retention and de novo urgency symptoms.Additional information has been requested.

• Brand Name: ULTRAPRO MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON GMBH; p.o. box 1409 d22841; norderstedt ; GM
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6990902
• MDR Text Key: 90693717
• Report Number: 2210968-2017-70706
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention