MAUDE Adverse Event Report: PHARMA SEPT LTD. STERILE SONOGRAPHY COVER WITH ADHESIVE AREA; SONOGRAPHY COVER / TRANSDUCER ULTRASONIC DIAGNOSTIC

Lot Number 7085570195

Device Problems Output Problem (3005); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

Event Type  malfunction  

Event Description

Surgeon noted that the neoprobe device was completely exposed from the sterile bag (safersonic sterile-sonography cover) after using it on the patient.Patient received additional dose of antibiotics and antibiotic irrigation was used after the discovery of the event.Diagnosis or reason for use: left breast wire localized lumpectomy, oncoplasty closure 24.Is the product compounded? no.Is the product over-the-counter? no.

• Brand Name: STERILE SONOGRAPHY COVER WITH ADHESIVE AREA
• Type of Device: SONOGRAPHY COVER / TRANSDUCER ULTRASONIC DIAGNOSTIC
• Manufacturer (Section D): PHARMA SEPT LTD.; caesarea 30889 00; IS 3088900
• MDR Report Key: 7868653
• MDR Text Key: 120243859
• Report Number: MW5079712
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2020
• Device Lot Number: 7085570195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR