MAUDE Adverse Event Report: COV LP/LLC, AUGUSTA VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7148

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 5/15/17.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer states that the gauze is spraying onto the sterile field.The customer is concerned with infection.

• Brand Name: VISTEC
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COV LP/LLC, AUGUSTA; 1647 perkins rd; augusta GA 30913
• Manufacturer (Section G): COV LP/LLC, AUGUSTA; 1647 perkins rd; augusta GA 30913
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6567781
• MDR Text Key: 75211585
• Report Number: 1018120-2017-05035
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 05/15/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1