MAUDE Adverse Event Report: COVIDIEN, FORMERLY TISSUE SCIENCE LABOR UNKNOWN PELVICOL PRODUCT; MESH, SURGICAL, POLYMERIC

Model Number UNK PELVICOL

Device Problem Extrusion (2934)

Patient Problem Injury (2348)

Event Date 08/19/2004

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.Patient underwent operation on (b)(6) 2007 for status post mid suburethral synthetic uretex t-o sling with extrusion of mesh and chronic discharge and drainage secondary to #1.

Manufacturer Narrative

(b)(4).

Event Description

Interventional surgery - coaptite injection: (b)(6) 2016: underwent exam under anesthesia, cystoscopy with peri-urethral bulking injections of coaptite to augment previous tot sling.

Manufacturer Narrative

Medtronic complaint report; (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received, additional implant surgery (b)(6) 2006: underwent examination under anesthesia, mild sub-urethral trans-obturator uretex sling and cysto scopy for recurrent stress urinary incontinence, mixed incontinence with detrusor instability, failed previous retropubic/suprapubic pelvilace sling, mild intrinsic sphincter deficiency under general anesthesia.

• Brand Name: UNKNOWN PELVICOL PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• MDR Report Key: 6108954
• MDR Text Key: 60094928
• Report Number: 9617613-2016-00089
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK PELVICOL
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2016
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR