MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ANCILLARY, HEADBAND UL PLUS BI; N/A

Catalog Number AX1375BIF

Device Problem Temperature Problem (3022)

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

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

On 7/18/17 integra investigation completed.Method: failure analysis, device history evaluation results: failure analysis - complaint is unconfirmed; this is due to the product not being returned for review.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order / manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Repair history: n/a.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.

Event Description

Fda medwatch # mw5070455 reports the plastic portion of headlight melted on physician's head and pungent "formaldehyde" like gas into his mask and therefore his lungs.

• Brand Name: ANCILLARY, HEADBAND UL PLUS BI
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6735519
• MDR Text Key: 80793855
• Report Number: 2523190-2017-00076
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• PMA/PMN Number: K864380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AX1375BIF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/24/2017
• 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: Unknown
• Patient Sequence Number: 1