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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 Herpes (1898); Incontinence (1928); Itching Sensation (1943); Abnormal Vaginal Discharge (2123); Injury (2348)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Incident date was not provided. Lot number not provided udi not provided. Re-processing information not provided 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 stress urinary incontinence with anterior vaginal wall defect. The procedure performed was an anterior vaginal wall repair and suburethral sling.

 
Manufacturer Narrative

Corrected information: date of birth, no eval explain code. 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 Key6423834
MDR Text Key70539282
Report Number9617613-2017-05042
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 ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 03/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2017
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 Received03/24/2017
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: 03/22/2017 Patient Sequence Number: 1
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