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

Catalog Number 720X

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018, the user facility reported that a cardio-vascular surgeon finished a case and noticed a strike-through, there was blood around his elbow.The gown was not returned for evaluation.A level iii gown is the recommended choice of barrier protection for the case that was performed.The sales/customer representative and the general manger reviewed the packs the hospital receives and it was discovered that they receive level ii and level iv gowns.Novo health services is working with the facility to add level iii gowns to their inventory.It was discussed with the facility the importance of returning any product that a discrepancy has been noted.There has been no further information provided.

Event Description

On (b)(6) 2018, the user reported, by email, to their sales representative that they had a strikethrough.

• 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 ; 5133986406
• MDR Report Key: 8101435
• MDR Text Key: 128403981
• Report Number: 1000306225-2018-00015
• 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: 01/01/2005,11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 720X
• 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