MAUDE Adverse Event Report: NOVO HEALTH SERVICES SURGICAL CONVIENCE KIT; LEVEL II REUSABLE STANDARD SURGICAL GOWN XLG

Model Number 7004

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event occurred with no patient delays, cancelation of procedures, or injury to the user.The gown was not returned.The end-user did not wear the appropriate level of gown for the 2.5-hour surgical case.The user was wearing a standard level two xxl gown, and it is recommended that a level three or higher should be worn.The client relations staff member is working with the facility to add level three gowns.

Event Description

The user facility reported that after the surgical procedure, the staff member removed their l2 reusable surgical gown and noticed strikethrough.

• Brand Name: SURGICAL CONVIENCE KIT
• Type of Device: LEVEL II REUSABLE STANDARD SURGICAL GOWN XLG
• Manufacturer (Section D): NOVO HEALTH SERVICES; 7086 industrial row drive; mason OH 45040
• Manufacturer (Section G): NOVO HEALTH SERVICES; 7086 industrial row drive; mason OH 45040
• Manufacturer Contact: zillery fortner ; 7086 industrial row drive; mason, OH 45040 ; 5133986406
• MDR Report Key: 9288377
• MDR Text Key: 203664543
• Report Number: 1000306225-2019-00004
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00812564030382
• UDI-Public: 00812564030382
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7004
• Device Catalogue Number: PACK 1154D
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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