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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Erosion (1750); Erythema (1840); Fever (1858); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Pain (1994); Scarring (2061); Tissue Damage (2104); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Fungal Infection (2419); Hematuria (2558); Blood Loss (2597); Dysuria (2684)
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. " sample not received.
Event Description
The patient's attorney alleged a deficiency against the device. It was reported by the patient¿s attorney that as a result of having the product implanted, the patient has experienced irritation from catheter, vaginal discharge, vaginal pain, chronic granulation tissue in vagina, persistent vaginal irritation, persistent vaginal bleeding, bacterial vaginosis, vaginitis, erythema, chronic low back pain, abdominal pain, mild left lower quadrant discomfort, chronic pelvic pain, suprapubic discomfort, left groin pain and drainage, occult erosion with persistent pain and irritation, pelvic abscess with right groin, tenderness over bladder neck, urinary mixed incontinence, stress urinary incontinence, leakage, urinary frequency, urinary retention, voiding dysfunction, extrinsic sphincter deficiency status-post anterior vaginal wall reconstruction, microhematuria, pyuria, dysuria, trace bacteruria, vaginitis yeast infection, postoperative infection, intermittent fevers, febrile urinary tract infection (pseudomonas), intermittent hematuria, lower urinary tract problems, drainage of bloody fluid, mild bloody drainage from previous drain site, intermittent bleeding from previous groin exploration, draining sinus in intra-abdominal wall, pelvic hematoma, hypermobility of urethra, thickening and change in left lower quadrant area, postsurgical changes at bladder neck, heterotopic ossification related to surgery, ill-defined stranding, soft tissue fullness within subcutaneous fat overlying low left pelvis, changes in left hemipelvis, hyperplastic tissue, granulation tissue in urethra very thin, involved bladder neck, collection of pelvilace material in suprapubic area, small capsular area in suprapubic area, exposed mesh on right side near bladder neck, unspecified extrusion, unspecified bowel problems, unspecified recurrence, dyspareunia, vaginal scarring, back aches, depression, vaginal and bladder infections, inability to hold bladder, painful intercourse, left groin abscess, closure of anterior wall, residual graft material with removal and sling redo and required multiple surgical interventions.
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Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
angela robinson
8195 industrial blvd
covington, GA 30014
MDR Report Key8697062
MDR Text Key147999033
Report Number1018233-2019-03120
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Device Age7 MO
Event Location Hospital
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2006
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: 06/13/2019 Patient Sequence Number: 1