MAUDE Adverse Event Report: NOVO HEALTH SERVICES NOVO HEALTH SERVICES; SURGICAL GOWNS

Model Number 642000

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that the decontamination technicians removed their gown and noticed that the area around their stomach was wet.Decon personnel should wear aami barrier level 4 gown.The user facility did not return the product back to be evaluated.The user facility informed the quality manager that the gown was light and the wrong level.The quality manager made the pack building team aware of the complaint and ensured they understood the policies and procedures.No further information was provided.

Event Description

On (b)(6) 2018, the user reported, that when the workers removed their gowns from decontamination room, their scrubs were wet on their stomach area.The supervisor stated that "they were not the correct gowns".

• Brand Name: NOVO HEALTH SERVICES
• Type of Device: SURGICAL GOWNS
• Manufacturer (Section D): NOVO HEALTH SERVICES; 1416 dogwood way; mebane NC 27302
• Manufacturer (Section G): NOVO HEALTH SERVICES; 1416 dogwood way; mebane NC 27302
• Manufacturer Contact: zillery fornter ; 7086 industrial row drive; mason, OH 45040 ; 5133986406
• MDR Report Key: 7893519
• MDR Text Key: 121462040
• Report Number: 1000306225-2018-00013
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): Y
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/01/2005,09/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 642000
• Device Catalogue Number: 642000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other