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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Blood Loss (2597); Not Applicable (3189)

Event Date 01/01/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on unknown date and the mesh was implanted anterior and posterior.Some years later, the patient experienced recurrent bleeding, discharge and vaginal infections.This appears to be due to mesh exposure in the vagina.She also had issues with urinary incontinence.The patient ultimately underwent several procedures first to trim exposed mesh and address granulation tissue in 2014.

Manufacturer Narrative

Date sent to the fda: 01/25/2020 additional information: b3, d8 corrected b5 narrative: it was reported that the patient underwent an unknown gynecological procedure on unknown date and the mesh was implanted anteriorly and posteriorly.Some years later, the patient experienced pain, recurrent bleeding, discharge and vaginal infections.This appears to be due to mesh exposure in the vagina.She also had issues with urinary incontinence.The patient ultimately underwent several procedures first to trim exposed mesh and address granulation tissue in 2014.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9630210
• MDR Text Key: 185912577
• Report Number: 2210968-2020-00708
• 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,other
• Type of Report: Initial,Followup
• Report Date: 01/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention