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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC

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TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 482027
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Erythema (1840); Incontinence (1928); Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Pulmonary Dysfunction (2019); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Arthralgia (2355); Numbness (2415); Obstruction/Occlusion (2422); Dysuria (2684); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
Alternative summary report attached for exemption (b)(4). Report includes the event specified within this mdr. -procode: ftl -reporting period: september 1, 2018 through october 31, 2018 -total number of events: 16 (0 new event reports, 16 supplemental event reports) -total events per brand name: pelvicol (10 events) ugytex (6 events). If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
Alternative summary reporting exemption (b)(4). The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of urinary stress incontinence. It was reported that after implant, the patient experienced dysuria, muscle weakness, joint pain, pelvic pain, dizziness, numbness, low back pain, hip pain, tingling, burning sensation, tenderness, swelling, urge incontinence, urinary frequency, muscle pain, muscle spasms, soreness, discomfort, erythema, bladder that doesn't empty, decreased physical activity, bowel obstruction, chronic constipation, unspecified neuromuscular disorder, additional surgical and nonsurgical interventions.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMESH TSL - PELVICOL¿
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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8102612
MDR Text Key128307213
Report Number9617613-2018-00115
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number482027
Device Catalogue Number482027
Device Lot Number09B05-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2018
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: 11/26/2018 Patient Sequence Number: 1
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