MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275)

Event Date 02/14/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) device not returned.Additional information of index procedure: report of surgery from (b)(6) 2012.Post-hysterectomy genital prolapse, tricompartmental, without urinary incontinence.Surgical approach : vaginal.Anterior sagittal colpotomy after infiltration with diluted xylocaine adrenaline.Dissection of the cystocele and opening of the para-vesical fossae which is more difficult on the left side.Spine spotting sciatica of the tendon arch and the posterior surface of the obturator foramen.Posterior sagittal coipotomy after infiltration with diluted xylocaine adrenaline, leaving an apical vaginal bridge approximately 3 cm between the two colpotomies.Dissection of the rectocele and opening of the ischio-rectal fossae and identification of the sacroépinous ligament.At the apical level, a tunnel is created behind the vaginal bridge, about 2 cm wide, allowing the apical prosthesis to be threaded.Placement of a total prolift (polypropylene) with an anterior subbladder part secured to the tendon arch of the pelvic fascia by two arms on each side, an apical part behind the apex and a pre-rectal part attached to the sacra-spinous ligament by one arm on each side exiting via the retro anal translevatorian approach.Solidarity of the anterior prosthesis to the fascia under the bladder neck by two stitch of vicryl rapid.Blue bladder test confirming bladder integrity.The absence of tension is checked at the apical portion of the prosthesis.Tr to debride the rectum.Vaginal mesh and indwelling probe 24h.Cutaneous suture with vicryl rapid.  the following information was requested, but unavailable: the patient demographic info: age, weight, bmi at the time of index procedure what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? product code and lot # were any concomitant procedures performed? results of the medical intervention given for the pain management? if reoperation was performed please provide date and surgical findings was the device removed? if so, please date and details of the re-operation.The initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? mesh exposure symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and surgical findings.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? what medical intervention was performed for the urinary tract infection? results? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? adverse events for the patient's event on 06/25/2012 reported via mw # 2210968-2021-04355 adverse events for the patient's event on 01/07/2013 event reported via mw # 2210968-2021-04356.

Event Description

It was reported that a patient underwent a patient underwent a gynecological procedure for post-hysterectomy genital prolapse, tricompartmental on (b)(6) 2012 and the mesh was implanted.It was reported that the patient's symptoms did not improve.It was reported that the patient's consequences included intense pains and repeated urinary tract infection treated with morphin since 2013.It was also reported that a cystoscopy revealed the patient had synechiae that needed to be removed under a short general anesthesia procedure.It was also reported that the patient sometimes had the occurrence of pollakiuria.An intervention for the patient was schedule on (b)(6) 2013.Additional information was requested.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL ¿ NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11794398
• MDR Text Key: 262199443
• Report Number: 2210968-2021-04357
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• 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: 04/08/2021
• 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