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U.S. Department of Health and Human Services

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

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COVIDIEN, FORMERLY TISSUE SCIENCE LABOR UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNK PELVICOL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Urinary Frequency (2275); Injury (2348); No Code Available (3191)
Event Date 08/07/2002
Event Type  Injury  
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. (b)(4).
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a pubovaginal sling done in conjunction with laparoscopic assisted vaginal hysterectomy and anterior and posterior repair. The preoperative and postoperative diagnosis was stress urinary incontinence. On (b)(6) 2003 the patient underwent a cystoscopy with bladder biopsy and examination under anesthesia. The preoperative diagnosis was frequency and urgency. The postoperative diagnosis was a normal cystoscopy and normal examination under anesthesia with small areas of erythema on posterior bladder wall.
 
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Brand NameUNKNOWN PELVICOL PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
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 avenue
north haven, CT 06473
2034925267
MDR Report Key6186123
MDR Text Key62746910
Report Number9617613-2016-00143
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
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 Received11/23/2016
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: 12/19/2016 Patient Sequence Number: 1
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