SURGICAL CAMERA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-02 for SURGICAL CAMERA manufactured by .

Event Text Entries

[3680366] Patient stated that she had a surgical procedure done to remove uterine polyps, scar tissue and one of her fallopian tubes. She had three incisions. She reported that one of the incision sites was where the surgical camera entered. The next day she began to experience pain. Two days later she alleged that the pain felt like stabbing knives along with fever. She also noticed that she was red from her belly button to her past cesarian incision site and across to both hips. She called her doctor, as instructed, she stated that he told her that it was too soon for infection to set in. By the 5th day she was rushed to the hospital and admitted. After discharge, she went to her doctor for follow-up. He took a sample from the incision. She alleged that the test came back positive for (b)(6). She immediately had surgery to remove as much of the infected tissue as possible. She was discharged from the hospital with a wound vac after 2 months. The pt believes that the surgical camera is the source of the (b)(6). She stated that the only site that was infected was the one that the camera entered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5031269
• MDR Report Key: 3265837
• Date Received: 2013-08-02
• Date of Report: 2013-08-02
• Date of Event: 2013-05-03
• Date Added to Maude: 2013-08-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: SURGICAL CAMERA
• Product Code: KQM
• Date Received: 2013-08-02
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2013-08-02