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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 Abdominal Pain (1685); Fatigue (1849); Gastritis (1874); Incontinence (1928); Irritation (1941); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Injury (2348); Depression (2361); Sleep Dysfunction (2517); Weight Changes (2607); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

(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

The patient¿s attorney alleged a deficiency against the device. Additional information has been requested, but not yet received. The preoperative diagnosis and postoperative diagnosis was sui. The procedure performed was a bladder mesh sling. Per additional information received, the patient has experienced suprapubic/right lower abdominal pain (abdominal pain), urinary frequency, uncontrollable urinary leakage, post-menopausal, constipation, mixed/urge/stress incontinence, pain in stomach, leakage, vaginal discharge, vaginal irritation, urinary frequency, elevated body mass index, chronic back pain, colon polyps/diverticulosis, depression, fatigue, weight up/down (weight fluctuations), sleeping poorly (sleep disturbances), chronic antral gastritis, and required additional surgical and non-surgical interventions.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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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
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6413036
MDR Text Key70301573
Report Number9617613-2017-05039
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received02/15/2017
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: 03/17/2017 Patient Sequence Number: 1
Treatment
IN-FAST
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