MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; DRESSING,BURN,18"X18",50PLY,STERILE,LF

Model Number	NON7915
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by facility and sales representative, (b)(6) inc.Who provided the following additional information in regards to this reported incident."i sent your questions to the customer and here's all they responded, "it happens with most of the patients that they apply this product to especially around the edges.They will find that the strings detach from the dressing itself and embeds itself into the wounds.They're having to pick it out of the fibers during dressing changes or baths.Move the fibers causes discomfort to the patient but no long lasting effects noted." no samples are available for return and evaluation.Therefore, a root cause maybe difficult to impossible to determine.No further information has been provided.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It has been reported, sterile burn dressings, 18" x 18 "is shedding quite a bit and embedding into wounds and they then have to pick pieces out.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: DRESSING,BURN,18"X18",50PLY,STERILE,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11634630
• Report Number: 1417592-2021-00057
• Device Sequence Number: 14221301
• Product Code: NAB
• UDI-Device Identifier: 10080196288656
• UDI-Public: 10080196288656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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: Health Professional
• Device Model Number: NON7915
• Device Catalogue Number: NON7915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention