MAUDE Adverse Event Report: ETHICON INC. PROSIMA ANTERIOR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PROA1

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Pain (1994)

Event Date 09/21/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported by the patient that they underwent an unknown procedure on (b)(6) 2010 and mesh was implanted.Following the procedure, the patient experienced mesh that came through the vaginal wall.The patient reported problems with hips and legs and pain in lower abdomen.No additional information was available.

• Brand Name: PROSIMA ANTERIOR 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; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8117286
• MDR Text Key: 128894528
• Report Number: 2210968-2018-77403
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2018

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: 09/30/2012
• Device Catalogue Number: PROA1
• Device Lot Number: 3417883
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention