MAUDE Adverse Event Report: NOVO HEALTH SERVICES OH GOWN, SURGICAL L2; LEVEL II SURGICAL GOWN

Model Number 7000

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

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

On 03/23/2021, the end-user reported a strikethrough on a reusable surgical level ii gown.The strikethrough was noticed once the gown was removed in the arm area.The staff member wore the gown for a total shoulder.The gown was sent back to the facility for investigation.The facility misplaced the gown.There is no reported injury or follow-up care.The facility took the following actions: testing the samples of l2 gowns by hydrostatic testing, no concerns noted.Awareness documented training was provided to the employees.Review of laundry titration reports four weeks before, no issues noted.Review of data entry into the computer system for preprogrammed barrier testing; no issues noted.Review of processes and procedures, no updates needed.Verified barrier training is current.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

The user facility reported a strikethrough on a reusable surgical level ii gown.

• Brand Name: GOWN, SURGICAL L2
• Type of Device: LEVEL II SURGICAL GOWN
• Manufacturer (Section D): NOVO HEALTH SERVICES OH; 7086 industrial row drive; mason OH 45040
• Manufacturer Contact: zillery fortner ; 7086 industrial row drive; mason, OH 45040 ; 5133986406
• MDR Report Key: 11706197
• MDR Text Key: 246695751
• Report Number: 1000306255-2021-00001
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 7000
• Device Catalogue Number: 700X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: No
• 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