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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC

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TISSUE SCIENCE LABORATORIES 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 Incontinence (1928); Pain (1994); Injury (2348); Prolapse (2475); Hematuria (2558)
Event Type  Injury  
Manufacturer Narrative
Corrected information: sex, date of birth, no eval explain code. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). Device mfg date: since the lot number was not provided, this information cannot be determined.
 
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 preoperative and postoperative diagnosis was pelvic prolapse with stress urinary incontinence. The procedure performed was a complex cystocele repair with graft and mid urethral sling and sacrospinous fixation and rectocele repair. On (b)(6) 2010, the patient underwent an additional procedure. The preoperative and postoperative diagnosis was hematuria. The procedure performed was a cystoscopy. On (b)(6) 2015 the patient underwent an additional procedure. The preoperative and postoperative diagnosis was stress urinary incontinence, cystocele, and incomplete bladder emptying. The procedure performed was a cystoscopy. The patient returned for an office visit on (b)(6) 2015. The patient had a sense of incomplete bladder emptying and had 2 urinary tract infections in the last 2-3 months. She had occasional suprapubic discomfort. The patient returned for an office visit on (b)(6) 2015 for urinary incontinence. The patient had persistent urinary and fecal incontinence. She stated that she had a slow stream and doesn't have normal sensation when her bladder was full. Her prolapse sensation had worsened significantly which made urinating difficult. She was not sexually active due to dyspareunia.
 
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Brand NameUNKNOWN PELVICOL PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
sharon murphy
15 hampshire street
mansfield, MA 02048
2034925267
MDR Report Key6347765
MDR Text Key248322783
Report Number9617613-2017-05008
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 Attorney
Type of Report Initial,Followup
Report Date 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2017
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 Received01/25/2017
Was Device Evaluated by Manufacturer? No
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: 02/21/2017 Patient Sequence Number: 1
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