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

Device Problem Extrusion (2934)

Patient Problem Erosion (1750)

Event Date 06/06/2018

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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure date and name of initial surgical procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications product code and lot number what is physician¿s opinion as to the etiology of or contributing factors to this event? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and surgical findings.What is the patient's current status?.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and the mesh was implanted.The patient experienced mesh extrusion and underwent excision.Additional information has been requested.

Manufacturer Narrative

Pc-000212748 date sent to the fda: 07/31/2018 additional information requested and following obtained: unable to obtain any further information relating to this complaint.

• Brand Name: PROSIMA 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 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7661698
• MDR Text Key: 113166824
• Report Number: 2210968-2018-74083
• 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,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/04/2018
• Supplement Dates FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention