MAUDE Adverse Event Report: POLYPROPYLENE MESH SLING; STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Chest Pain (1776); Micturition Urgency (1871); Itching Sensation (1943); Pain (1994); Rash (2033); Urinary Retention (2119); Sore Throat (2396); Ambulation Difficulties (2544); Skin Burning Sensation (4540); Swelling/ Edema (4577)

Event Date 06/23/2021

Event Type  Injury  

Event Description

I had a cystocele mid urethral mesh sling, rectocele, pelvic reconstruction surgery at (b)(6) hospital.I was sent home with a catheter on same day of surgery, instructed to take it off the following day( (b)(6) 2021) i had urine retention so ended up in my local er hospital room.Hospital placed a new catheter, i called (b)(6) gynecology clinic to inform.I was ordered by dr (b)(6) to leave on catheter for an additional 3 days.Took of catheter 72 hrs later and i still suffer from urine retention.I ended visiting er for placement of a catheter.Called (b)(6) gynecology clinic and was instructed to leave on catheter for an additional 10 days until appt to see dr.I had to visit a local obgyn due to constant urge to urinate accompanied by pain and pressure.Dr said i should be on antibiotics due to possible uti and having catheter on for many days.I saw (b)(6) dr 2 weeks after surgery date.I explained to her i was having side effects: swelling on right pelvic side, urine retention, small rashes appearing through my body, not being able to walk due to a burning and pulling pain on pelvic wall area.Dr.(b)(6) did a vaginal exam she said everything looked good, little swelling around bladder and possible inside right side bruising.She asked to self catheterize everyday and a follow up visit in a week.Follow up visit 7 days later; i shared with dr (b)(6) my side effects were getting worse.The rashes were now showing all over my body (head to toe) with itching and burning feeling.I also started having chest pains, tight pressure pain when taking deep breaths and pain in throat.She then advised i go to er when experiencing those symptoms.I have been having these symptoms everyday for about 10 days now, the burning on right side pelvic area is strong, and rashes on body are constant throughout the day.The chest pressure is daily as well.I had to visit er room on (b)(6) 2021 due to these side effects.Dr.(b)(6), at (b)(6) has requested a takedown of the polypropylene mesh sling that was performed on june 23, 21.Fda safety report id # (b)(4).

• Brand Name: POLYPROPYLENE MESH SLING
• Type of Device: STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR
• MDR Report Key: 12203693
• MDR Text Key: 263222805
• Report Number: MW5102677
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 71