MAUDE Adverse Event Report: NOVO HEALTH SERVICES SURGICAL CONVENIENCE KIT; SURGICAL GOWN

Model Number 700*

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Human Factors Issue (2948)

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

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event occurred with no patient delays, cancellations of procedures, or injury to user.The appropriate level of gown was not used for the surgical procedure, leg amputation.The user was wearing a level 2 gown and should have been wearing a level 4 gown.The sales member held a meeting with the hospital and they will now order premium l4 pack with gown, part 6701f.

Event Description

The user facility reported that at the end of a surgical procedure, leg amputation, an employee observed a strikethrough on their surgical gown.

• Brand Name: SURGICAL CONVENIENCE KIT
• Type of Device: SURGICAL GOWN
• Manufacturer (Section D): NOVO HEALTH SERVICES; 1416 dogwood way; mebane NC 27302
• Manufacturer (Section G): NOVO HEALTH SERVICES
• Manufacturer Contact: rebecca cox ; 1416 dogwood way; mebane, NC 27302
• MDR Report Key: 7322295
• MDR Text Key: 101984898
• Report Number: 1000306225-2018-00005
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 700*
• Device Catalogue Number: 700*
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other