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U.S. Department of Health and Human Services

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

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

 
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Brand NameSURGIPRO
Type of DeviceMESH, 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 Key9146893
MDR Text Key160931254
Report Number1219930-2019-05539
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK915526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 10/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSPM-35-W
Device Catalogue NumberSPM-35-W
Device LOT NumberA2D184
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
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: 10/02/2019 Patient Sequence Number: 1
Treatment
UNKNOWN IVS TUNNELLER DEVICE, LOT# UNKNOWN
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