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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 PEL220
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, multiple medical complications occurred after implant of the device. The product used for therapeutic treatment of genital ptosis characterized by a large externalized rectocele. Stage 2 cystocele and stage 2 hysteroptosis were noted. It was reported that after implant, the patient experienced lower abdominal/lumbar/sacrum/rectum pain, un-emptied bladder, incompletely empty bladder sensation, and frequent urination. After a post-operative cesarean section, the patient continues to experience urinary/rectal problems, painful bending, appendicitis-like pains, and tugging/shearing pain. The patient has had rectal manometry, mri, and echo, with no results to explain the pain. The patient has also had a sub-total hysterectomy/bilateral salpingectomy preserving the cervix/ovaries/collar, but the symptoms are the same.
 
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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 Key8570553
MDR Text Key143737510
Report Number9617613-2019-00062
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPEL220
Device Catalogue NumberPEL220
Device Lot Number08B06-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2019
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: 05/01/2019 Patient Sequence Number: 1
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