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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent to the fda: 08/20/2015 (b)(4) no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2009 and a mesh and bs-advantage sling were implanted.It was reported that the patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 1/29/2016.(b)(4).It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2009 and a mesh was implanted due to sui and cystocele.It was reported that following insertion the patient experienced infection, urinary problems, recurrence, bleeding, dyspareunia and vaginal scarring.It was reported that patient underwent mesh removal and repair of inguinal hernia with alloderm mesh due to infection, recurrent hernia and pain on (b)(6) 2008.No additional information was provided.

Manufacturer Narrative

It was reported that the patient underwent a gynecological procedure and mesh was implanted along with concurrent anterior repair due to sui and cystocele.It was reported that following insertion the patient experienced infection, urinary problems, recurrence, bleeding, dyspareunia and vaginal scarring.No additional information was provided.

• Brand Name: GYNECARE PROLIFT 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: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 5018766
• MDR Text Key: 23603229
• Report Number: 2210968-2015-11895
• 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
• Reporter Occupation: Other
• Type of Report: Followup,Followup,Followup,Followup
• Report Date: 12/08/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/29/2016; 02/05/2016; 08/23/2016; 12/14/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 56 YR