MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; DRAPE, SURGICAL, EXEMPT

Model Number	DYNJP2499
Health Effect - Clinical Codes	Bruise/Contusion (1754); Skin Discoloration (2074)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Sterile blue film "u" drape caused bruising to patient's upper arm below tourniquet.The medline drape piece is so sticky, almost toxic like, when removing it is causing bruising and or skin tears to patients.The skin discoloration is noticed immediately after removing.Similar event also happened in the fall.

• Brand Name: MEDLINE
• Common Device Name: DRAPE, SURGICAL, EXEMPT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 12967486
• Report Number: 12967486
• Device Sequence Number: 14586081
• Product Code: PUI
• UDI-Device Identifier: 10080196739462
• UDI-Public: (01)10080196739462
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2021
• Report Date (Section F): 11/05/2021

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
• Device Model Number: DYNJP2499
• Device Catalogue Number: DYNJP2499
• Device Lot Number: 0692108H012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 95 KG
• Patient Race: White
• Date Report Sent to FDA: 11/05/2021