MAUDE Adverse Event Report: NOVO HEALTH SERVICES GOWN, SURGICAL; REUSABLE SURGICAL GOWN

Model Number	PACK 123688D COMPONENT 7005
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Receipt by User (1570); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020, the end-user reported a debris found on a reusable surgical gown (7005) while setting up the case.The gown was inside a spine pack 123668.The gown was not sent back to the facility for testing.Awareness documented training was provided to the employees.Historical review of titration reports, no quality exceptions were recorded.Review of the product that the customer orders and discussion on barrier levels.Review our processes and procedures; no updates needed.The root cause for the reported issue is wearing the wrong barrier level product for a orthopedic hip procedure.There is no additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
On (b)(6) 2020 the end-user reported finding debris on the gown, during the case set-up.

• Brand Name: GOWN, SURGICAL
• Common Device Name: REUSABLE SURGICAL GOWN
• Manufacturer (Section D): NOVO HEALTH SERVICES; 6024 century oaks dr; chattanooga, tn
• MDR Report Key: 9690142
• Report Number: 1000306225-2020-00002
• Device Sequence Number: 2401838
• Product Code: FYA
• UDI-Device Identifier: 00812564033192
• UDI-Public: 00812564033192
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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: PACK 123688D COMPONENT 7005
• Device Catalogue Number: PACK 123688D COMPONENT 7005
• Device Lot Number: 219568
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/10/2020
• 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