MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-06-11 for CAREFUSION PURESOM RUBY ADJUSTABLE TMS-09 ADJ manufactured by Carefusion 211, Inc..
[4593697]
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. "
Patient Sequence No: 1, Text Type: D, B5
[12109525]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1424490-2014-00001 |
| MDR Report Key | 3883992 |
| Report Source | 00 |
| Date Received | 2014-06-11 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-05-12 |
| Date Facility Aware | 2014-05-01 |
| Report Date | 2014-05-12 |
| Date Mfgr Received | 2014-05-12 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2014-07-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES STYTLE |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal | 92262 |
| Manufacturer Phone | 7608837120 |
| Manufacturer G1 | CAREFUSION 205, INC. |
| Manufacturer Street | 4153 W. 166TH ST. |
| Manufacturer City | OAK FOREST IL 60452 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60452 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREFUSION |
| Generic Name | STRAP, HEAD, GAS MASK |
| Product Code | BTK |
| Date Received | 2014-06-11 |
| Returned To Mfg | 2014-05-22 |
| Model Number | PURESOM RUBY ADJUSTABLE |
| Catalog Number | TMS-09 ADJ |
| Lot Number | 011013A01 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 211, INC. |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-11 |