MAUDE Adverse Event Report: NOVO HEALTH SERVICES NOVO HEALTH SERVICES; LEVEL II GOWN

Model Number 7002X

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

The end user finished a two hour open reduction internal fixation (orif) of a distal femur, as she removed the level ii surgical gown (7002) strikethrough was observed on the left forearm (size 4x6").The recommended gown level for an orif is a level iv or iii gown.The gown was not provided.Currently the end user has not had any follow up care.(b)(6) hospital currently does not supply level iii surgical gowns in a medium.The client relations manager is working with the customer to provide level iii surgical gowns.

Event Description

The end user reported strikethrough on the left forearm of a level 2 gown.

• Brand Name: NOVO HEALTH SERVICES
• Type of Device: LEVEL II GOWN
• Manufacturer (Section D): NOVO HEALTH SERVICES; 6024 century oaks drive; chattanooga TN 37416
• Manufacturer (Section G): NOVO HEALTH SERVICES; 6024 century oaks drive; chattanooga TN 37416
• Manufacturer Contact: zillery fornter ; 7086 industrial row drive; mason, OH 45040 ; 5133986406
• MDR Report Key: 8357573
• MDR Text Key: 136736939
• Report Number: 1000306225-2019-00002
• 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: 01/01/2005,02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7002X
• Device Catalogue Number: 7002
• Device Lot Number: 41873001
• 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: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other