• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN LP LLC NORTH HAVEN MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNK SURGIPRO MESH
Device Problems Extrusion (2934); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Menstrual Irregularities (1959); Tissue Damage (2104); Injury (2348); Blood Loss (2597); No Code Available (3191)
Event Date 09/15/2017
Event Type  Injury  
Event Description
According to the reporter: the patient had a mesh inserted during a vaginal hysterectomy and anterior repair. Post-operatively the patient has had recurrent abnormal vaginal bleeding secondary to mesh extrusion and infection. The patient also had vulval lichen sclerosis. The mesh was completely excised and unhealthy vaginal tissue around mesh was biopsied. The patient had undergone cystourethroscopy, vaginal mesh excision, vaginal biopsy and vulval biopsy. Patient had distressed injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6940996
MDR Text Key89022528
Report Number1219930-2017-07905
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 09/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK SURGIPRO MESH
Device Catalogue NumberUNK SURGIPRO MESH
Device Lot NumberUNKNOWN
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 Received09/21/2017
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: 10/11/2017 Patient Sequence Number: 1
-
-