MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES -3004086170 PELVISOFT ACELLULAR COLLAGEN BIOMESH

Catalog Number 481812

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Internal Organ Perforation (1987); Hematuria (2558)

Event Type  Injury  

Manufacturer Narrative

The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the precautions: pelvisofttm biomesh is for single-patient use only and is to be implanted surgically.If either the outer polyester/polyethylene pouch or the inner foil pouch has been perforated or torn in shipment or storage, then the enclosed pelvisofttm biomesh should not be used.Pelvisofttm biomesh should be hydrated or moist when the package is opened.Dehydrated or dry tissue should not be implanted.(b)(4).The total number of events for product classification code ftm is (b)(4).(b)(4) - pelvisoft acellular collagen biomesh.(b)(4) - pelvisoft acellular collagen biomesh, 4cm x 7cm.(b)(4) - pelvisoft acellular collagen biomesh, 6cm x 8cm.(b)(4) - pelvisoft acellular collagen biomesh, 8cm x 12cm.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Sample not received.

Event Description

It was reported in the patient's medical records that as a result of having the product implanted, the patient has experienced fecal soiling, vaginal atrophy, vaginal discharge, rectal prolapse, burning with urination (burning sensation), rectal, back, pelvic, loin and groin pain, ureteral colic, intrinsic sphincter deficiency, recurrent urinary tract infections (uti), urinary urgency, urinary frequency, nocturia, scarring, unaware/urge/stress/mixed incontinence, failed spinal nerve stimulator (failure of implant), constant urinary leakage, diarrhea, gastroesophageal reflux disease, blood in urine (hematuria), protein/nitrites/leukocytes in urine, benign neoplasm, left upper thigh lesion with itching (itching), vaginal and abdominal cramps, elevated blood pressure, hot flashes, moderate erosive gastritis, duodenitis, colitis (inflammation), abdominal pain, internal hemorrhoids, scattered diverticulosis, heartburn, epigastric pain, gastric ulcerations, hiatal hernia, menopause, osteopenia, left upper thigh condyloma/viral wart, escherichia coli in urine (bacterial infection), bladder perforation (organ perforation) and required non-surgical and additional surgical interventions.

• Brand Name: PELVISOFT ACELLULAR COLLAGEN BIOMESH
• Type of Device: PELVISOFT ACELLULAR COLLAGEN BIOMESH
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES -3004086170; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES -3004086170; astley lane industrial estate; unit 1; swillington, leeds LS26 8XT; UK LS26 8XT
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5494541
• MDR Text Key: 40127941
• Report Number: 1018233-2016-00269
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Catalogue Number: 481812
• Device Lot Number: 08B21-8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR