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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

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.Citation: int j colorectal dis (2010) 25:881¿886; doi 10.1007/s00384-010-0931-8.

Event Description

It was reported via journal article: "title: posterior sagittal approach for mesh rectopexy as a management of complete rectal in adults" author(s): yehia kosba &walid galal elshazly & walid abd el maksoud citation: int j colorectal dis (2010) 25:881¿886; doi 10.1007/s00384-010-0931-8.The aim of this study was to evaluate prospectively the functional outcome of posterior sagittal rectopexy with prolene mesh for rectal prolapse in young adults.Between jan2005 and feb2008, 32 patients (n=21 male and n=11 female; mean age of 36.7 years [ranging 28 to 45 years]) with complete rectal prolapse underwent posterior sagittal approach prolene mesh rectopexy.In the procedure the prolene mesh (t-form poly-proplene mesh) was sutured to the lateral and posterior aspects of the rectum, then fixing and suspending prolene sutures were passed in the back and lateral aspects of the sacrum then in the polypropylene mesh, and the seromuscular coat of the posterior and lateral surfaces of the rectum.Vicryl sutures were used in approximation of the levators and para-sagittal muscles of both sides.The skin incision was closed with closed suction drain.Postoperatively, complication included a single case of recurrence of prolapse (3.22%), which was managed by trans-abdominal resection rectopexy, and mucosal prolapse occurred in two patients (6.44%), which was managed by rubber band ligation.The findings indicate that posterior sagittal rectopexy with prolene mesh in young adults with rectal prolapse is an effective technique, with excellent functional results and without major morbidities.

• 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 0151
• Manufacturer (Section G): ETHICON INC.; 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 Key: 7594570
• MDR Text Key: 110873602
• Report Number: 2210968-2018-73432
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• 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