MAUDE Adverse Event Report: COVIDIEN 6114 OIL EMULSION DRS 3 X 16; BANDAGE, LIQUID

Model Number	6114
Medical Device Problem Code	Inadequate Lubrication (4057)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation due to the pandemic; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the gauze adheres to the wound bed causing trauma, pain and bleeding upon removal, in addition to destroying the granulation tissue already formed.For this reason, they apply pure petroleum jelly on the product to keep the moisture and to ensure that the gauze does not adhere to the skin.

• Brand Name: 6114 OIL EMULSION DRS 3 X 16
• Common Device Name: BANDAGE, LIQUID
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 11233392
• Report Number: 1018120-2021-00432
• Device Sequence Number: 4069401
• Product Code: KMF
• UDI-Device Identifier: 10884521068629
• UDI-Public: 10884521068629
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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: 6114
• Device Catalogue Number: 6114
• Device Lot Number: 20A080362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1