MAUDE Adverse Event Report: NOVO HEALTH SERVICES TN GOWN, SURGICAL L4; LEVEL IV GOWN

Model Number 7800

Device Problem No Apparent Adverse Event (3189)

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

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020, the end-user reported a strikethrough in the reusable surgical level iv gown.The staff member was wearing the ppe in spd, and when the gown was removed, their scrubs were wet.They did not isolate the gown to send back to the facility to complete an investigation; therefore, a definitive root cause or verification of the strikethrough could not be determined.The facility took the following actions: awareness documented training was provided to the employees.Random inspections of patched areas, with no issues noted.Random inspections with barrier testing, no issues noted.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.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

The user facility reported a strikethrough of a reusable level iv gown.

• Brand Name: GOWN, SURGICAL L4
• Type of Device: LEVEL IV GOWN
• Manufacturer (Section D): NOVO HEALTH SERVICES TN; 6024 century oaks drive; chattanooga, tn
• Manufacturer Contact: zillery fortner ; 7086 industrial row drive; mason, oh ; 3986406
• MDR Report Key: 10171065
• MDR Text Key: 198337834
• Report Number: 1000306225-2020-00006
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982694
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7800
• Device Catalogue Number: 780*
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2020
• 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