MAUDE Adverse Event Report: COVIDIEN, FORMERLY TISSUE SCIENCE LABOR UNKNOWN PELVICOL PRODUCT

Model Number UNK PELVICOL

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

Patient Problems Abdominal Pain (1685); Incontinence (1928); Injury (2348); Constipation (3274)

Event Date 05/14/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

Procedure: urogynecological.The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2013: mild urinary and mild fecal incontinence, constipation, bloating dysfunction, incomplete bladder emptying, mild cystocele, pelvic pain, uti.Erosion of a uretex sup stitch that was removed in (b)(6) 2004 chronic pain in the pelvis.Urinary leakage associated with physical activity (jumping, coughing, laughing).On (b)(6) 2016: stress urinary incontinence, cystocele-midline, urethral hypermobility, interstitial cystitis, bladder pain, chronic cystitis, urinary urgency, pelvic pain.Additional implant (using advantage fit) surgery: on (b)(6) 2016: underwent retropubic mid urethral sling (advantage fit), anterior colporrhaphy, cystoscopy with hydrodistention, trigger point injection-3 pelvic muscles for stress urinary incontinence, cystocele-midline, urethral hypermobility, interstitial cystitis, bladder pain, chronic cystitis, urinary urgency, urinary hesitancy, pelvic pain under general anesthesia.

• Brand Name: UNKNOWN PELVICOL PRODUCT
• Type of Device: UNKNOWN PELVICOL
• Manufacturer (Section D): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer (Section G): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473
• MDR Report Key: 6087724
• MDR Text Key: 59455065
• Report Number: 9617613-2016-00079
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

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?: Yes
• Device Operator: No Information
• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK PELVICOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR