MAUDE Adverse Event Report:

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Pocket Erosion (2013); Dyspareunia (4505)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Additional information received on 03/01/2021 reported that between (b)(6) 2017 and (b)(6)2019, the patient experienced vaginal irritation, poking sensations, acute post-operation complications, uti, vaginal pain and discharge with odor, urinary frequency and burning, a feeling of mesh curing, acute vaginitis, bladder mesh infection, odor with urination, foul odor in vagina, elevated wbc in urine, frequent uti, claimant can feel sling with her fingers with self vaginal exam, urgency, leg and back pain, sciatica, back spasms, and pain in right leg.Additional information received on 05/18/2021 reported mesh exposure on right fornix, bleeding, and dyspareunia.Additional information received on 06/18/2021 reported urinary incontinence, pelvic pain, vaginal pain, recurrent mui, urinary frequency with urgency, and palpable mesh on right at mid-urethra with tenderness/mesh exposure.Additional information received on 07/15/2021 reported the patient experiences chronic urinary leakage which results in the patient wearing a pad at all times.The patient now feels like there is something poking her in pelvic/vaginal area ui.She is experiencing pelvic pain, mui symptoms, and thinks she has more sling/mesh erosion (chronic mui, chronic pelvic pain).On (b)(6) 2021 an in-office cystoscopy showed no erosion into the bladder.The physician was unable to visualize palpable sling/mesh exposure/erosion within distal vagina ~11:00 position.At this time, the patient stated that since the sling/mesh excision she has always been able to feel the sling/mesh with her finger, recently she now feels a wire in her vagina, worsening dyspareunia, occasional sharp vaginal pain, ui symptoms since sling/mesh excision, leaking with laugh/cough/sneeze/lifting, wears 2-3 pads/day, urinary frequency/urgency.Palpable/tender sling/mesh at right midurethra, mui (stress > urge).She states would like sling/mesh surgically removed and will address mui postoperatively.On (b)(6) 2021 patient underwent removal of midurethral sling with revision, and examination under anesthesia.Intraoperative findings: (1 x 2 cm) left sling/mesh arm noted (excised with suture intact), right sling/mesh arm noted within a tract towards obturator internus (flap created for excision), suture fragments noted in left fornix, sling/mesh and suture noted from right fornix, evidence of previous partial excision of right sling/mesh arm.Ongoing bilateral sling/mesh exposure, vaginal bleeding, dyspareunia.

Event Description

This report is a follow-up to mfr report # 2125050-2020-00454.

• MDR Report Key: 12302180
• MDR Text Key: 265866821
• Report Number: 2125050-2021-01128
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 4957073
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 08/10/2021
• Date Device Manufactured: 03/31/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR