MAUDE Adverse Event Report: COVIDIEN VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7148

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/18/2017.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer states the gauze is falling apart on the edges.

Manufacturer Narrative

The lot number provided by the customer was not a valid lot number therefore a device history record review could not be completed.There was no physical sample received for this report therefore the root cause of the reported condition stated by the customer could not be determined.As no physical samples were received for evaluation, the root cause of the reported condition stated by the customer could not be determined and subsequently no formal investigation actions are being taken at this time.Should a sample be returned in the future, the complaint shall be re-evaluated at that time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISTEC
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer (Section G): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6958558
• MDR Text Key: 89859498
• Report Number: 1018120-2017-05102
• 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,Followup
• Report Date: 02/20/2018

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: Health Professional
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: PR300758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1