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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABOR (INACTIVE) UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC

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TISSUE SCIENCE LABOR (INACTIVE) UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNK PELVICOL
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Urinary Frequency (2275); Injury (2348); Hematuria (2558)
Event Type  Injury  
Manufacturer Narrative

Manufacturer reference number: (b)(4). 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. The procedure performed was an endoscopic bladder neck suspension. The patient returned for an office visit on (b)(6) 2002. The patient is continuing intermittent catheterizations but described that her residual urines had been consistently less than two ounces. She was having some vaginal discharge but no incontinence. The patient returned for an office visit on (b)(6) 2002. The patient had some mild intermittency. The patient returned for an office visit on (b)(6) 2002. The patient had started having frequency and a little bit of gross hematuria but no dysuria over the past four or five days. The patient returned for an office visit on (b)(6) 2002. Since the last office visit the patient has not picked up and started urinating. The patient was not voiding at all and was catheterizing herself five to six times per day and was not having any significant pain except for some cramps when her bladder was full. The patient had some mild obstipation problems. An additional procedure was performed on (b)(6) 2002. The preoperative and postoperative diagnosis was urinary retention following bladder neck suspension. The procedure performed was a cystoscopy and removal of bladder neck suspension sutures.

 
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 LABOR (INACTIVE)
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABOR (INACTIVE)
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
sharon murphy
15 hampshire street
mansfield, MA 02048
2034925267
MDR Report Key6344110
MDR Text Key67804885
Report Number9617613-2017-05003
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 01/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2017
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 Received01/25/2017
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: 02/20/2017 Patient Sequence Number: 1
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