MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN MESH NORTH HAVEN - SURGIPRO¿; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN - SPRO

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Incontinence (1928); Injury (2348); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The pre and post-operative diagnosis was mixed urinary incontinence and pelvic organ prolapse.The patient underwent a procedure for robotic hysterectomy with bilateral salpingo-oophorectomy.(b)(6) 2010 - procedure for robotic-assisted laparoscopic abdominal sacral colpopexy, cystoscopy, transobturator sling placement (obtryx), rectocele repair and perineoplasty with the pre and post-operative diagnosis of vaginal prolapse and stress urinary continence.(b)(6) 2011 - procedure for retropubic sling placement (advantage), sling revision and incision, urethrolysis, rectocele repair and plastics closure of introitus.The pre and post-operative diagnosis was stress urinary continence, rectocele and dyspareunia.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH NORTH HAVEN - SURGIPRO¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6623199
• MDR Text Key: 77019042
• Report Number: 1219930-2017-05737
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN - SPRO
• Device Catalogue Number: UNKNOWN - SPRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• 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): Other; Required Intervention
• Patient Age: 56 YR