MAUDE Adverse Event Report: PHILIPS ORAL HEALTHCARE, INC. SONICARE; AIRFLOSS EFS

Model Number HX8140

Device Problem Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, customer claims unit smelled and tasted like nail polish remover.

Manufacturer Narrative

On 11/25/2014 received the unit in used, but clean condition, no charger base provided.Will not turn on and fire.Placed handle on charger, but unit will not charge.Inspection of internal components revealed a swollen battery with residue exiting the battery and entering plunger shaft as well as small amount of corrosion on plunger spring.Smell similar to antifreeze around battery as well as in plunger shaft, base of plunger with residue at base and on plunger seal.Inspection of the droplet generator revealed the cup valve was not seated and was sideways in the recess.Msds from (b)(4) lithium battery has indicated that ingestion hazards due to overexposure are as follows: "ingestion of electrolyte solution causes tissue damage to throat area and gastro/respiratory tract.Ingestion of cobalt and cobalt compounds are considered to be possible human carcinogen(s)" msds pdf sheet included as attachment.As the customer complains only of taste and smell and not skin or throat irritation, do not have reason to assume that the customer has been overexposed.Recommend having mdr eval.The root cause of the customer's complaint was due to swollen battery with failed battery seal.On (b)(4) 2014, after review of failure analysis, it was determined that the root cause found was reportable.

• Brand Name: SONICARE
• Type of Device: AIRFLOSS EFS
• Manufacturer (Section D): PHILIPS ORAL HEALTHCARE, INC.; bothell WA
• Manufacturer Contact: mary smith ferreira ; 1600 summer st.; stamford, CT 06905 ; 2033515949
• MDR Report Key: 4360394
• MDR Text Key: 16635042
• Report Number: 3026630-2014-00038
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/16/2014

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: Lay User/Patient
• Device Model Number: HX8140
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1