MAUDE Adverse Event Report: CAREFUSION 211, INC. CAREFUSION; STRAP, HEAD, GAS MASK

Model Number PURESOM RUBY ADJUSTABLE

Device Problems Use of Device Problem (1670); Biocompatibility (2886)

Patient Problems Itching Sensation (1943); Rash (2033); Discomfort (2330)

Event Date 05/12/2014

Event Type  Other  

Event Description

An email was sent to sleep support via the carefusion website.It read: "i'm guessing that you have changed the manufacturing of your chin strap.I loved the first one i had, but it got old and somewhat fuzzy.The new one itched from the first day i wore it, almost like fiberglass fibers in my chin.I washed it several times and it was very slightly better.However, now i have a rash from it and have discontinued using it.".

Manufacturer Narrative

The end user/patient did not submit a user facility/importer report to the manufacturer.Event codes were derived based on info provided by the end user/patient.(b)(4).The puresom ruby adjustable chinstrap has been received, routed to the carefusion failure analysis lab and staged for evaluation.Once the evaluation is completed, a f/u medwatch report will be submitted.

• Brand Name: CAREFUSION
• Type of Device: STRAP, HEAD, GAS MASK
• Manufacturer (Section D): CAREFUSION 211, INC.; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION 205, INC.; 4153 w. 166th st.; oak forest IL 60452
• Manufacturer Contact: james stytle ; 1100 bird center drive; palm springs, CA 92262 ; 7608837120
• MDR Report Key: 3883992
• MDR Text Key: 4593697
• Report Number: 1424490-2014-00001
• Device Sequence Number: 1
• Product Code: BTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PURESOM RUBY ADJUSTABLE
• Device Catalogue Number: TMS-09 ADJ
• Device Lot Number: 011013A01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2014
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2014
• Device Age: 15 MO
• Event Location: Home
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other