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

Model Number 441603

Device Problem Material Separation (1562)

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 3/21/2017.An investigation is currently underway; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with surgical gauze.The customer states that the gauze are fraying and leaving debris of little thread.

• Brand Name: DERMACEA
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6421907
• MDR Text Key: 70549869
• Report Number: 3011410703-2017-00058
• 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: 02/21/2017

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: 441603
• Device Catalogue Number: 441603
• Device Lot Number: 16031601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1