MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; GOWN,SIRUS,NON REINFRCD,LARGE,SET IN SL

Model Number	DYNJP2001S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that surgical gown material was coming off the product.The material, described as "fuzz" by the reporting facility, was reportedly entering the surgical site.A concern for a "retained item" and an "inflammatory response" was expressed by the reporting facility, however, no information was received to indicate that any adverse patient impact had occurred.Despite multiple good faith attempts, the reporting facility was unable or unwilling to provide additional information beyond what was originally reported.A sample was returned to the manufacturer for evaluation.Inspection of the returned sample found the reported "fuzz" material on the body and on the left sleeve of the surgical gown.A root cause was unable to be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that surgical gown material was coming off the product.

• Brand Name: MEDLINE
• Common Device Name: GOWN,SIRUS,NON REINFRCD,LARGE,SET IN SL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11946902
• Report Number: 1417592-2021-00096
• Device Sequence Number: 4752233
• Product Code: FYA
• UDI-Device Identifier: 10080196304660
• UDI-Public: 10080196304660
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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: DYNJP2001S
• Device Catalogue Number: DYNJP2001S
• Device Lot Number: 72520060120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/07/2021
• 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: Other