FDA Adverse Event Injury Summary report: N

SAFYRE SLING

MDR report key: 7813350 · Received August 23, 2018

Report

Report Number
MW5079386
Event Type
Injury
Date Received
August 23, 2018
Date of Event
August 9, 2014
Report Date
August 22, 2018
Manufacturer
UNK
Product Code
PWJ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
AS
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON THIS DATE, I HAD A HYSTERECTOMY AND SAFYRE SLING INSERTED TO TREAT STRESS INCONTINENCE. WHICH I WAS TOLD WAS A SIMPLE SURGERY WITH LESS THAN 3/4% OF COMPLICATIONS. AFTER THE SURGERY, I WAS UNABLE TO EMPTY MY BLADDER AND I HAD A CATHETER FOR A WEEK. THE SLING WAS TOO TIGHT THE DR SAID. I STARTED GETTING INFECTIONS AND SUFFERING FROM INTENSE PAIN IN URETHRA. I WAS UNABLE TO EMPTY MY BLADDER. I WAS SELF CATHETERISING. FOUR WEEKS LATER I HAD SURGERY TO LOOSEN SLING. I NO LONGER NEEDED TO SET CATHETERIZE BUT THE PAIN AND INFECTION PROBLEMS REMAINED. SURGERY AGAIN THIS TIME THEY CUT THE SLING ON THE OTHER SIDE. THIS HELPED REDUCE THE PAIN. I CONTINUE TO GET INFECTIONS EVERY 4/5 WEEKS. PAIN STARTED WORSENING. AFTER SEEING A UROLOGIST AND HAVING HER CLEAN OUT MY BLADDER (IT WAS COVERED IN BLISTER LIKE SKIN, ANOTHER SURGERY) THE INFECTIONS EASED OFF BUT THE PAIN REMAINED. I WENT BACK TO GYNECOLOGIST WHO DID ORIGINAL SURGERY. HE FELT INSIDE MY VAGINA AFTER I TOLD HIM MY SYMPTOMS. HIS FACE DROPPED AS HE REALIZED THE RIGHT HAND SIDE OF THE SLING HAD COME LOOSE AND THE PLASTIC ANCHOR WAS SITTING BUNCHED UP MY URETHRA. HE SCHEDULED ME FOR ANOTHER SURGERY AND REMOVED THIS PART OF THE SLING. IT IS NOW ALMOST 4 YRS SINCE IMPLANTATION AND I STILL SUFFER FROM PAIN IN THE URETHRAL AREA AND INFECTION SYMPTOMS. WHICH I BELIEVED ARE CAUSED BY THE MESH THE DR IMPLANTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
652727 SAFYRE SLING STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR PWJ UNK

Patients

Seq Age Sex Outcome Treatment
1 46 YR Hospitalization| R