MAUDE Adverse Event Report: NATIONAL BIOLOGICAL CORP. HOUVA 4; PHOTOTHERAPY UNIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Injury (2348)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

During discussion with (b)(6) clinicians, it was found that the facility was not following nbc's recommended / published protocol (koo).The facility was advised to utilize only nbc recommended and published protocols, as outlined in the ifu, for safe and effective treatment.The facility was following all other nbc guidelines.

• Brand Name: HOUVA 4
• Type of Device: PHOTOTHERAPY UNIT
• Manufacturer (Section D): NATIONAL BIOLOGICAL CORP.; 1532 enterprise pkwy.; twinsburg OH 44087
• Manufacturer Contact: 23700 mercantile rd; beachwood, OH 44122 ; 2168310600
• MDR Report Key: 4805594
• MDR Text Key: 5927616
• Report Number: 1521608-2015-00002
• Device Sequence Number: 1
• Product Code: KGL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Remedial Action: Inspection
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1