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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN SURGIPRO MESH MESH, SURGICAL, POLYMERIC

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COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN SURGIPRO MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPM35
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Seroma (2069); Urinary Tract Infection (2120); Discharge (2225); Injury (2348); Obstruction/Occlusion (2422); Hematuria (2558); Blood Loss (2597); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191)
Event Date 12/21/2010
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 a hernia. It was reported that after implant, the patient experienced infection, migrations, organ perforation, organ damage, severe and permanent physical and emotional injuries, fistulous serous fluid drainage, non-purulent material, serosanguinous, wound infection, fistula, purulent drainage, brown-tinged lymphatic drainage, spontaneous bleeding, uti, hematuria, pyelonephritis, mild right-kidney obstruction, right flank pain, adhesions and fibrosis. Post-operative patient treatment included additional surgical intervention.
 
Manufacturer Narrative
(b)(4). Lot number not provided. Udi not provided. Re-processing information not provided. Since the lot number was not provided, this information cannot be determined.
 
Event Description
According to the reporter: the patient had a mesh implanted during hernia repair surgery. On or around (b)(6) 2013 the patient underwent a ct scan and it was determined that there was a foreign object in her bladder. On or around (b)(6) 2013 the patient underwent revision surgery to remove the mesh. The patient suffered severe and permanent physical and emotional injuries included but not limited to infection, migrations, organ perforation, organ damage and other serious life threatening injuries.
 
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Brand NameUNKNOWN SURGIPRO MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN, FORMERLY US SURGICAL A DIVISON
60 middletown ave
north haven CT 06473
Manufacturer (Section G)
COVIDIEN, FORMERLY US SURGICAL A DIVISON
60 middletown ave
north haven CT 06473
Manufacturer Contact
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6256558
MDR Text Key106765058
Report Number1219930-2017-00068
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,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPM35
Device Catalogue NumberSPM35
Device Lot NumberA7A594
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 Received08/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/17/2017 Patient Sequence Number: 1
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