MAUDE Adverse Event Report: ETHICON INC. TOTAL PELVIC FLOOR REPAIR SYST; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRT01

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

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Abnormal Vaginal Discharge (2123)

Event Date 05/31/2006

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure: 61y, unsure bmi/weight at time of procedure but currently 75kg and 168.4cm.Name of initial surgical procedure? anterior and posterior vaginal repair, bilateral sacrospinous fixation with mesh (total prolift), tvt-o and cystoscopy can you confirm that gynecare prolift mesh and gynecare tvt-o mesh were both implanted on (b)(6) 2006? yes.The diagnosis and indication for the initial surgical procedure with prolift and tvt-o? pelvic organ prolapse and stress urinary incontinence the diagnosis and indication for the surgical procedure with tvt on (b)(6) 2007? recurrent stress incontinence.What were current symptoms following the index surgical procedure? onset date? unsure onset; vaginal spotting/discharge.Other relevant patient history/concomitant medications ¿ previous hysterectomy, previous bulking agent; mesh exposure 2015 ¿ partial excision.Product code and lot number for tvt-o? not available.Product code of prolift mesh? pfrt01 lot 1403066.Product code of tvt mesh? 810041b lot 3135641.The initial approach for the index surgical procedure? vaginal.Any concurrent procedure/device implantation? only as detailed.Were there any intra-operative complications? nil.When was the mesh exposure first noted by a physician? 2015.Mesh exposure site/location, symptoms and diagnostic confirmation? 2015 ¿ anterior vaginal mesh exposure 4mm; had partial excision; 2020 ¿ 1.5cm midline anterior vaginal mesh exposure.Describe any medical/surgical intervention for exposure including dates and surgical findings.(b)(6) 2015 excision mesh exposure for 4mm anterior mesh exposure; (b)(6) 2020 ¿ surgical excision mesh exposure for 1.5cm mesh exposure which mesh type was removed during excision? total prolift what is physician¿s opinion as to the etiology of or contributing factors to this event? n/a.What is the patient's current status? bleeding settled.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Adverse event regarding tvt-o mesh submitted via 2210968-2020-09162.Adverse event regarding prolift mesh submitted via 2210968-2020-09163.Adverse event regarding tvt mesh submitted via 2210968-2020-09164.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2006 and mesh was implanted.The patient experienced repeat mesh exposure with bleeding in (b)(6) 2020 and underwent partial mesh excision on (b)(6) 2020.Additional information was requested.

• Brand Name: TOTAL PELVIC FLOOR REPAIR SYST
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11216569
• MDR Text Key: 232831486
• Report Number: 2210968-2021-00592
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2007
• Device Catalogue Number: PFRT01
• Device Lot Number: 1403066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR