MAUDE Adverse Event Report: UNKNOWN VAGINAL MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 10/05/2023

Event Type  Injury  

Event Description

"my name is (b)(6), i was scheduled to have a mesh implant for urinary continence.I stayed a little longer in the hospital after the surgery not being able to get up.After the surgery i was discharged with no doctor note for work excuse for recovery, neither was i given pain medication.I was told to take tylenol.I bleed for two weeks straight.I was in a lot of pain not able to walk or sit up straight.My pelvic area was swollen and i couldn¿t sit straight due to the pressure.My bladder felt squeezed and ready to explode.It also felt like an open cut getting bigger every time i urinate.When i returned to work, i couldn¿t perform my daily assignments as a child care provider.On friday, (b)(6), i made appointment with my primary doctor and told her i was not making any progress healing and i was getting worse.The doctors run some test and i got infection and the mesh looked too tight.I went to see dr (b)(6) performed the mesh surgery, in.Dr (b)(6) informed me the mesh was too tight and a stitch ripped rubbing against mesh hence the chronic abdominal pain and not being able to walk or stand.He cut the mesh without anesthesia in his clinic and recommended a clean surgery to remove mesh.I need another.Axminster providence medical group.Pelvic prolapse.".

• Brand Name: VAGINAL MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18103980
• MDR Text Key: 327995407
• Report Number: MW5148006
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2023
• Patient Sequence Number: 1
• Treatment: HUMALOG + INSULIN PUMP.; IBUPROFEN.; LEXAPRO.; MAGNESIUM.; MILK THISTLE.; POTASSIUM.; SYNTHROID.
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native