UNKNOWN TSL

MDR report key: 3250713 · Received July 19, 2013

Report

Report Number: 9617613-2013-00573
Event Type: Injury
Date Received: July 19, 2013
Date of Event: November 20, 2007
Report Date: July 1, 2013
Manufacturer: COVIDIEN, FORMERLY TISSUE
Product Code: FTL
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

PROCEDURE TYPE: STRESS UI/PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD EXPERIENCED INCOMPLETE BLADDER EMPTYING, URINARY RETENTION SECONDARY TO PUBOVAGINAL SLING, APICAL VAGINAL VAULT PROLAPSE, RECURRENT URINARY INCONTINENCE, PERSISTENT ELEVATED POSTVOID RESIDUAL URINE (POSTOPERATIVELY, INCREASING, PER (B)(6) 2008 OPERATIVE REPORT), SEVERE SCARRING OF THE ANTERIOR VAGINAL WALL ALONG THE URETHRA, SIGNIFICANT RETRACTION OF THE VAGINAL MUSCOSA INTO THE INTENSE SCAR TISSUE, PELVICOL GRAFT WAS "COMPLETELY ENCAPSULATED WITH NO EVIDENCE OF TISSUE INGROWTH INTO THE MATERIAL", A BAND OF TISSUE PRESENT AT THE PROXIMAL URETHRA ADJACENT TO THE BLADDER NECK, TRANSVERSE FIBERS OF THE PREVIOUS RECTUS FASCIA SLING COULD BE IDENTIFIED, THE URETHRA WAS THIN AND SCARRED AT SITE OF THE PREVIOUS RECTUS FASCIA SLING, THE RECTUS FASCIA SLING WAS SCARRED TO THE URETHRA ALONG THE SITES OF THE MESH SLING LOCATION, AND THE RETROPUBIC SPACE WAS SCARRED SIGNIFICANTLY FROM THE RECTO FASCIA SLING AND THE 2 PREVIOUS MESH TAPE SLINGS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
339011	UNKNOWN TSL	BIOLOGIC MESH	FTL	COVIDIEN, FORMERLY TISSUE		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR