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

Model Number SPM-35-W

Device Problems Extrusion (2934); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Erythema (1840); Granuloma (1876); Hematoma (1884); Irritation (1941); Itching Sensation (1943); Pain (1994); Abnormal Vaginal Discharge (2123); Anxiety (2328); Injury (2348); Depression (2361); Prolapse (2475); Fluid Discharge (2686); Foreign Body In Patient (2687); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

Medtronic complaint number: pe:(b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. 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. Product was used for therapeutic treatment. Procedure performed: total vaginal hysterectomy, posterior repair, tension-free vaginal tape (tvt) vaginal sling and cystoscopy. Alleged complications post implant: overactive bladder , rectal pain, constipation, vaginal itching, discharge, odor, recurrence and bleeding. Mesh revision surgery: (b)(6) 2004: underwent removal of vaginal mesh for extruded foreign body from vagina under general anesthesia. Alleged complications such as perirectal hematoma, deep rectal pain up in the pelvic area and vaginal granulation tissue.

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: 6662275
• MDR Text Key: 78226655
• Report Number: 1219930-2017-05854
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/22/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: SPM-35-W
• Device Catalogue Number: SPM-35-W
• Device LOT Number: A2M14
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/22/2017 Patient Sequence Number: 1