MAUDE Adverse Event Report: LAPAROSCOPE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Vomiting (2144); Burning Sensation (2146)

Event Date 11/06/2018

Event Type  Injury  

Event Description

Went in on (b)(6) 2018 for a laparoscopic hysterectomy.(b)(6) i was able to be released from hospital but i was in a lot of pain.At one point i asked my doctor if i was going to die.They sent me home.On (b)(6), i called my doctor's office because i was having a lot of burning, they prescribed me a medication for the burning.(b)(6), i still was not myself, i was not able to eat or drink.I was throwing up, and leaving looked 4 months pregnant.Sunday i called ob, they told me i needed to go to urgent care because it sounded like the flu.I laid in bed about another hour threw up once more, got up, and my sister helped me get dressed and took me to hospital.I had scans done, blood work, and ultrasound.Ultrasound showed there was fluid left after surgery and blood work showed my kidneys were failing.My levels were at a 4.5.The doctors shipped me to (b)(6) where i had more blood work and waited hours in the er.My sister was with me when urology came in and explained what they were going to do, and my sister suggested them put a cath in.They were pumping me full of fluids.My levels come down after a while but i still needed surgery, there was a hole in my bladder.I had another laparoscopic surgery on (b)(6) and from this day until now i am under a lot of pain.

• Brand Name: LAPAROSCOPE
• Type of Device: LAPAROSCOPE
• MDR Report Key: 8191682
• MDR Text Key: 131588157
• Report Number: MW5082523
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 35 YR
• Patient Weight: 68