MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; SURGICAL GOWN, STERILE PACK

Model Number DYNJ21971T

Device Problem Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 07/05/2017

Event Type  malfunction  

Event Description

Scrubbed person on cabg procedure looked down at the gown during procedure and noticed fraying of the gowned material on the front of her gown.Procedure did last for hours.
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manufacturer response for surgical gown, custom cabg pack (per site reporter).
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the gown was evaluated in their biohazard lab and noted fraying on one of the sleeves of the gown.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: SURGICAL GOWN, STERILE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7233616
• MDR Text Key: 98762909
• Report Number: 7233616
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ21971T
• Device Catalogue Number: DYNJ21971T
• Other Device ID Number: CUSTOM CABG PACK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1