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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 Micturition Urgency (1871); Inflammation (1932); Itching Sensation (1943); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Fungal Infection (2419); Obstruction/Occlusion (2422)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
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. The procedure performed was an in-fast urethral sling with trocar cystostomy and vaginal hysterectomy. Between 8 days and 1 month post op the patient had incomplete bladder emptying, urinary retention, and bladder spasms. She was prescribed utira. Between 2 months and 5 months post op the patient had low back pain, painful urination for 2 to 3 days, frequency, urgency during the daytime, bladder spasm, urinary tract infection, and atrophic vaginitis treated with estrace ring. She was assessed with bladder outlet obstruction probably secondary to her sling. Between 2 years and 3 months and 2 years and 4 months the patient had vaginal discharge with itching, discomfort. There was yeast present and it was treated with diflucan. She was prescribed ciprofloxacin and pyridium.

 
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.

 
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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 Key6415471
MDR Text Key70301614
Report Number9617613-2017-05040
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
Report Date 02/15/2017
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
AMS IN-FAST BONE ANCHOR
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