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

Model Number SPM-35-W

Device Problems Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Purulent Discharge (1812); Foreign Body Sensation in Eye (1869); Perforation (2001); Swelling (2091); Injury (2348); Prolapse (2475); Blood Loss (2597); Dysuria (2684)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of rectocele in an anterior posterior pelvic floor repair.It was reported that within two months after implant, the patient experienced lower abdominal pain, vaginal bleeding, and dirty discharge.Later symptoms included mesh protrusion through the anterior vaginal wall, leaking pusfrom an incision made during the implant surgery, extrusion of the top of the vagina by the ivs tape, vaginal bleeding, granulation, cystic endometrium, buttock swelling, slight cystocele, foreign sensations, and painful micturition.Post-operative patient treatment included multiple revision surgeries to trim the mesh and ivs tape.

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9146893
• MDR Text Key: 160931254
• Report Number: 1219930-2019-05539
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521101371
• UDI-Public: 10884521101371
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SPM-35-W
• Device Catalogue Number: SPM-35-W
• Device Lot Number: A2D184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/02/2019
• 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
• Treatment: UNKNOWN IVS TUNNELLER DEVICE, LOT# UNKNOWN
• Patient Outcome(s): Required Intervention