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

Device Problem No Apparent Adverse Event (3189)

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

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that they were having concerns with strike-through.A conference call was held on (b)(6) 2018, the following departments were on the call; customer representative, corp qa/ra, quality manger, general manager, infection control from the hospital, surgical technologist experiencing the strike-through, and the nurse manager.It was discovered that the user could not wear the level iv x-large gown which was provided in the pack/kit.The user pulled a single level ii, medium gown for her cases, mainly orthopedic cases.Corporate qa/ra provided the hospital with suggested gown levels for surgery.The louisville depot sent over medium gowns for the facility to use.The user packs/kits where updated to include medium gowns.None of the strike-through products were returned.It was discussed that it is important to segregate and send back any items of concern for investigation.There has been no further information provided.

Event Description

On (b)(6) 2018, the user reported, by phone, to their support representative that they are having issues with strike-through.

• Brand Name: NOVO HEALTH SERVICES
• Type of Device: SURGICAL GOWNS
• Manufacturer (Section D): NOVO HEALTH SERVICES; 7086 industrial row drive; mason OH 45040
• Manufacturer (Section G): NOVO HEALTH SERVICES
• Manufacturer Contact: zillery fornter ; 7086 industrial row drive; mason, OH 45040
• MDR Report Key: 7986686
• MDR Text Key: 126110508
• Report Number: 1000306225-2018-00014
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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