MAUDE Adverse Event Report: COVIDIEN 6715 KERLIX RL STERILE 1'S; GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE

Model Number	6715
Medical Device Problem Codes	Material Fragmentation (1261); Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported they were using the gauze to bandage a surgical wound when they discovered the bandage was fraying and falling apart.There was no harm to the patient.
Event or Problem Description
Additional information was received from the customer stating the gauze was not used in a surgical setting.
Additional Manufacturer Narrative
Correction: additional information was received from the customer stating the gauze was not used in a surgical setting.Additional information: after additional information was received and with further review of the complaint details it was determined that this report was submitted in error as the incident does not meet the mdr regulation requirements of a reportable event.

• Brand Name: 6715 KERLIX RL STERILE 1'S
• Common Device Name: GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 8621263
• Report Number: 1018120-2019-00362
• Device Sequence Number: 16665688
• Product Code: NAB
• UDI-Device Identifier: 10884521058453
• UDI-Public: 10884521058453
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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
• Operator of Device: No Information
• Device Model Number: 6715
• Device Catalogue Number: 6715
• Device Lot Number: 18L121162
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 05/29/2019
• Patient Sequence Number: 1