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U.S. Department of Health and Human Services

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

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COVIDIEN LP LLC NORTH HAVEN MESH NORTH HAVEN- SURGIPRO MESH, SURGICAL, POLYMERIC Back to Search Results
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.

 
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Brand NameMESH NORTH HAVEN- SURGIPRO
Type of DeviceMESH, 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 Key6662275
MDR Text Key78226655
Report Number1219930-2017-05854
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received06/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSPM-35-W
Device Catalogue NumberSPM-35-W
Device LOT NumberA2M14
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 Received01/11/2017
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
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