SAFYRE SLING

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for SAFYRE SLING manufactured by Unk.

Event Text Entries

[118389082] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079386
MDR Report Key7813350
Date Received2018-08-23
Date of Report2018-08-22
Date of Event2014-08-09
Date Added to Maude2018-08-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSAFYRE SLING
Generic NameSTRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR
Product CodePWJ
Date Received2018-08-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-08-23

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