MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRP01

Device Problem Material Erosion (1214)

Patient Problems Bleeding (1738); Erosion (1750); Incontinence (1928); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported by the patient that she underwent a gynecological procedure on (b)(6) 2009 to treat bladder and bowel prolapse and mesh was implanted and a uterine ablation procedure was performed.On (b)(6) 2009 the patient experienced heavy vaginal bleeding.The patient returned to her physician on (b)(6) 2009 for persistent bleeding and minor urinary incontinence and a vaginal mesh erosion was observed and removed.In (b)(6) 2010 the patient discovered additional vaginal erosion upon experiencing dyspareunia.Vaginal bleeding continued and the patient returned to her physician on (b)(6) 2010 and a 2 cm linear vaginal mesh erosion was observed.On (b)(6) 2010 the patient underwent an additional surgical procedure including a vaginal hysterectomy to treat second degree uterine prolapse.The patient reports around (b)(6) 2010 increasing bowel problems including urgency and pain and recurrent dyspareunia.The patient returned to her physician on (b)(6) 2011 and additional mesh erosion was observed behind the introitus and in the midline of the vagina and another mesh removal procedure was done on (b)(6) 2011.The patient reports using diet modification, pain killers and enemas to manage persistent bowel problems.The patient began experiencing severe leg and buttock pain in approximately (b)(6) 2014 and saw a physician in (b)(6) 2014 who opined that the mesh is pulling on her nerves and recommended removal.The patient continues to experience prolapse, pain down both legs which causes mobility problems, bowel and pelvic pain and bouts of incontinence.Additional information was not provided.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4570238
• MDR Text Key: 21083736
• Report Number: 2210968-2015-02491
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2015

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: PFRP01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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