MAUDE Adverse Event Report: COVIDIEN WOUND CARE UNKNOWN; GAUZE SPONGE

Model Number UNKNOWN WOUND CARE

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date 12/22/2015.It was reported to covidien on (b)(4) 2015 that a customer had an issue with a gauze sponge.

Event Description

Customer reports that they are finding poor quality of the dermacea sponges.

Manufacturer Narrative

Submit date: (b)(6) 2016.The complaint report indicated that a returned sample was not expected and to date a sample has not been received.A photo was attached which appeared to show short gauze like fibers that could have originated from the gauze.This complaint will be re-opened should a sample be returned in the future.A device history record (dhr) review could not be performed because a lot number or product code was provided by the customer.All dhrs are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.A potential root cause for the reported condition can be a result of short fibers which are produced during the cutting process of the gauze.This can produce short fibers that appear frayed.A corrective and preventative action (capa) has been opened to address similar issues as the one described by the customer.This issue will be reviewed during the monthly report out for the factory.No changes to the quality control sampling plans are deemed necessary.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for trending purposes and reviewed with plant management.

• Brand Name: WOUND CARE UNKNOWN
• Type of Device: GAUZE SPONGE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5319807
• MDR Text Key: 34883715
• Report Number: 1018120-2015-00044
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN WOUND CARE
• Device Catalogue Number: UNK WC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1