MAUDE Adverse Event Report: ADVANCE MEDICAL DESIGNS, INC.; SYSTEM, DRAPE, X-RAY

Model Number 07-CA601

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/09/2018

Event Type  malfunction  

Event Description

The unopened c-drape had a long black hair in it.The package was still sealed.Luckily, the surgical technician saw the hair before she opened the package and the sterile field was not compromised.

• Type of Device: SYSTEM, DRAPE, X-RAY
• Manufacturer (Section D): ADVANCE MEDICAL DESIGNS, INC.; 1241 atlanta industrial drive; marietta GA 30066
• MDR Report Key: 8089046
• MDR Text Key: 127886090
• Report Number: 8089046
• Device Sequence Number: 1
• Product Code: KKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 07-CA601
• Device Catalogue Number: 07-CA601
• Device Lot Number: 80647C8150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2018
• Type of Device Usage: N
• Patient Sequence Number: 1