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); Pain (1994); Abnormal Vaginal Discharge (2123); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that a patient underwent a posterior pelvic floor repair procedure on an unknown date and mesh was implanted.The patient experienced vaginal erosion, vaginal discharge and discomfort.The eroded mesh was removed.Additional information was requested.

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

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a posterior pelvic floor repair procedure and an anterior colporrhaphy on (b)(6) 2007 and mesh was implanted.The patient experienced pain on post op day 5 and was diagnosed with constipation.The pain continued and she underwent an exam under anesthesia and the left wing of the mesh was excised.The pain resolved.She then developed vaginal spotting on (b)(6) 2012 and a stitch erosion was noted and removed.She continued to have vaginal bleeding and was diagnosed with a mesh erosion on (b)(6) 2014.She underwent an additional surgery on (b)(6) 2014 to remove the underlying eroded mesh.

• 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: 4391276
• MDR Text Key: 5307562
• Report Number: 2210968-2015-00091
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013718
• 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
• Report Date: 12/16/2014

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: 02/28/2009
• Device Catalogue Number: PFRP01
• Device Lot Number: 2968303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 01/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2006
• 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 Weight: 60