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

Catalog Number PFRT01

Device Problem Material Erosion (1214)

Patient Problems Blister(s) (1743); Erosion (1750); Foreign Body Reaction (1868); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Urinary Retention (2119); Burning Sensation (2146); Cramp(s) (2193); 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 an attorney that the patient underwent a gynecological procedure on an undisclosed date and mesh was implanted into the patient.It is reported that the patient experienced pain, erosion of her internal tissues, and she has undergone additional surgeries and revisionary procedures.No additional information is provided at this time.

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.

Manufacturer Narrative

It was reported by the patient that she experienced recurrent infections with intake of antibiotics, hypertension, throat swelling, eating and swallowing problems, choking, stomach swelling and hardening with pain, eroded mesh into the inside wall of vagina causing inflammation and pain, dyspareunia, hurting joints, pain during walking, blood in stools, painful bowels, fatigue, water on her lungs, water retention, constant cough, food allergies, foreign body reaction, skin problems such as hives, blisters and staph infections, depression and emotional problems.(b)(4).

Manufacturer Narrative

Additional narrative: it was reported that the patient experienced bacterial vaginosis along with yeast infection, uterine wall thickening, swelling, water retention, cramping with sharp pain followed by a burning sensation, fatigue, energy loss and depression.It was reported that the patient is scheduled for tests, including an ultrasound and ekg.(b)(4) - fatigue; uterine wall thickening.

Manufacturer Narrative

It was reported that the patient underwent a gynecological procedure and mesh was implanted on (b)(6) 2006 along with concurrent hysteroscopy with thermal ablation due to sui.No additional information was provided.

Manufacturer Narrative

It was reported that following procedure in 2006 the patient the patient experienced a high blood pressure, a low grade fever, pain, swelling of the abdomen, cramping leg muscles and muscle atrophy.The patient reported that she has difficulties to go up stairs and grasping objects with her hands.The patient also states that she had erosion and it was excised from her vagina in 2006.It was reported that the patient experienced multiple vaginal infections, utis and continued to be under doctor¿s care over the past 3 years about infections.It was reported that the patient underwent an unknown surgery in 2008.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

It was reported that patient underwent mesh revision on (b)(6) 2008 by dr.(b)(6).

• Brand Name: GYNECARE PROLIFT TOTAL 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 0151
• 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: 3583515
• MDR Text Key: 4162608
• Report Number: 2210968-2014-00492
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2016

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 Expiration Date: 05/31/2007
• Device Catalogue Number: PFRT01
• Device Lot Number: 2928844
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 01/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/28/2014; 04/30/2014; 06/25/2014; 07/28/2014; 10/29/2014; 04/13/2016; 05/23/2016; 07/22/2016; 07/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2006
• 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
• Patient Age: 47 YR
• Patient Weight: 61