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

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that a patient underwent a pelvic floor repair procedure on an unknown date and mesh was implanted.Approximately 2 years following the procedure, the patient presented with a midline extrusion.The patient initially healed but later underwent another procedure for revision of the mesh.Additional information has been requested.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected narrative: it was reported that a patient underwent a pelvic floor repair procedure on an unknown date and mesh was implanted.Approximately 2 years following the procedure, the patient presented with a midline extrusion.The patient initially healed but later underwent another procedure for revision of the mesh.Additional information has been requested.

Manufacturer Narrative

It was reported that a patient underwent a sling procedure for the treatment of incontinence on (b)(6) 2011 and mesh was implanted.The patient experienced a 1cm of mesh protrusion through the vaginal wound and the 1cm of mesh was excised on (b)(6) 2011.An additional 1.5cm of mesh on the left was removed on (b)(6) 2012, as it still could be felt though the skin.On (b)(6) 2012, it was requested that all mesh be removed due to an ache in the pelvic.The current condition of the patient was reported as being fine.(b)(4).

• Brand Name: GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
• 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: 3776180
• MDR Text Key: 4361249
• Report Number: 2210968-2014-05366
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2014
• 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