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

Model Number PACK 123688D COMPONENT 7005

Device Problems Delivered as Unsterile Product (1421); Shipping Damage or Problem (1570); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 01/22/2020

Event Type  malfunction  

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 Description

On (b)(6) 2020 the end-user reported finding debris on the gown, during the case set-up.

• Brand Name: GOWN, SURGICAL
• Type of Device: REUSABLE SURGICAL GOWN
• Manufacturer (Section D): NOVO HEALTH SERVICES; 6024 century oaks dr; chattanooga, tn
• Manufacturer Contact: zillery fortner ; 7086 industrial row drive; mason, oh ; 3986406
• MDR Report Key: 9690142
• MDR Text Key: 204760077
• Report Number: 1000306225-2020-00002
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 00812564033192
• UDI-Public: 00812564033192
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other