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

MAUDE Adverse Event Report: COVIDIEN, FORMERLY TISSUE SCIENCE LABOR UNKNOWN PELVICOL PRODUCT

  • 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, FORMERLY TISSUE SCIENCE LABOR UNKNOWN PELVICOL PRODUCT Back to Search Results
Model Number UNK PELVICOL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Injury (2348); Hematuria (2558)
Event Date 05/09/2002
Event Type  Injury  
Manufacturer Narrative
Medtronic complaint report: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Per additional information received, the preoperative and postoperative diagnosis was stress urinary incontinence, cystocele. Underwent pubovaginal sling and anterior repair under general plus local infiltration anesthesia.
 
Manufacturer Narrative
(b)(4). (b)(6). User facility is listed in initial reporter. (b)(4).
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.
 
Manufacturer Narrative
Tracking number: (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
Alleged complications post device implant, microscopic hematuria-small amount, stress urinary incontinence, urgency and difficulty with urination. Intervention surgery occurred (b)(6) 2012; cystoscopy and fulguration of small hemangioma.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN PELVICOL PRODUCT
Type of DeviceUNKNOWN PELVICOL
Manufacturer (Section D)
COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
victoria house, victoria road
aldershot, hampshire
UK
Manufacturer (Section G)
COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
victoria house, victoria road
aldershot, hampshire
UK
Manufacturer Contact
sharon murphy
60 middletown ave
north haven 
MDR Report Key6108894
MDR Text Key274987705
Report Number9617613-2016-00087
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,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK PELVICOL
Device Catalogue NumberUNK PELVICOL
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 Received10/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/17/2016 Patient Sequence Number: 1
-
-