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

Model Number 780*

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020, the end-user reported that they had six strike throughs while wearing a reusable surgical level iv gown.The staff members worked in the decontamination area and were wearing the gown for ppe; strike throughs happened in the critical zone of the chest.The gowns were sent back to the facility for investigation.The facility took the following actions: the quality manager segregated the product and washed and dried the gowns.Then they were inspected on a light table.Two of the gowns had tiny holes in the chest area.The other four gowns passed inspections and barrier testing.The two gowns which had tiny holes failed barrier testing.The rifd tag was scanned to obtain the number of cycles per each gown.The two gowns that failed had 33 and 52 cycles.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.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

The end-user reported strike through on six-level four surgical gowns.

• Brand Name: GOWN, SURGICAL
• Type of Device: GOWN, SURGICAL LEVEL IV
• Manufacturer (Section D): NOVO HEALTH SERVICES TN; 6024 century oaks drive; chattanooga, tn
• Manufacturer Contact: zillery fortner ; 5155 westpark dr. sw; atlanta, ga ; 3986406
• MDR Report Key: 10411067
• MDR Text Key: 203663481
• Report Number: 1000306225-2020-00007
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 780*
• Device Catalogue Number: 780*
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2020
• 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