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

Model Number DYNJP2001S

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2021

Event Type  malfunction  

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 Description

It was reported that surgical gown material was coming off the product.

• Brand Name: MEDLINE
• Type of Device: GOWN,SIRUS,NON REINFRCD,LARGE,SET IN SL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 11946902
• MDR Text Key: 258979783
• Report Number: 1417592-2021-00096
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10080196304660
• UDI-Public: 10080196304660
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other