MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-03-28 for CAREFUSION PURESOM RUBY CHIN STRAP, MED TMS-09M manufactured by Carefusion 211, Inc..
[3201433]
[name removed] from technical support received an email complaint from a pt ([name removed]) he was wearing a chinstrap that was very tight on his face and caused bruising and swelling. I contacted the company he purchased it from ([company name removed]) and spoke to [name removed]. I am sending sample chinstrap's on (b)(4) to [name removed] for [name removed] as replacement options for the tms-09m that was too tight on his face. On (b)(6) 2013, the end user/pt reported: "the chin strap caused a very bad abrasion underneath my chin. It was bruised and swollen. When we [end user/pt and distributor's representative] met [distributor's representative name removed] told me that it would be tight and would loosen up but never mentioned it might cause me injury. It broke the skin and i have puss like marks in the area. It is very sore. Can you suggest how i might resolve this? Do i need to go see my doctor and has this happened to other of your clients? Is there a larger size version of this chin strap or is it the only size? Is there a way to stretch it so it still is effective in keeping my mouth closed during sleep? " "it is a few days later and the swelling has mostly gone down and the abrasions seem to be healing. I like the product as it seems to be a good solution to keeping my mouth closed during sleep. I'm concerned that it will cause further problems if i try to use it? Do you have a different size? Is there a way to stretch it a bit so i can wear it comfortable? I'm looking to [company name removed] to address my issue with your product and provide a solution. " on (b)(6) 2013 in response to a request for additional information the end user/pt reported: "the issue was i most likely received a chin strap that was too small. I did not realize it nor did [name removed] since i never tried it on and wore it all night and only discovered the problem when i awoke. " on (b)(6) 2013 in response to a request for additional information the end user/pt reported: "i did not see a doctor. There were abrasions on the underside of my mouth. They have healed and gone away. It turned out to be a minor thing, more annoying than painful. I have the chin strap and plan on bringing it back to the provider [company name removed] in (b)(6), when i receive the replacement strap. They can send it back to you, but there really is not anything to see. It was simply too small. " on (b)(6) 2013 in response to a request for additional information the end user/pt reported: "people rarely read instructions, myself included, especially when it looks straight forward, like putting on the strap. It's a pretty simple device. Your vendor never warned me about it being tight and i did not try it on. I did get the larger size, which is adjustable. I've worn it two nights and it seems to fit fine and is comfortable. "
Patient Sequence No: 1, Text Type: D, B5
[10639820]
Neither the end user/pt nor the distributor submitted a user facility/importer report to the manufacturer. Event codes were derived based on information provided by the end user and the distributor. (b)(4). Based on information provided by the end user, carefusion determined that the puresom ruby chin strap size medium provided by the distributor was too small for the end user/pt. Carefusion advised the end user/pt that there are other sizes of the puresom ruby chin strap available. The end user/pt reported that he did get the larger size, which is adjustable and that he has worn it for two nights, it seems to fit fine and is comfortable. A review of the carefusion complaint system for the past two years resulted in zero like incidents, thus at present carefusion considers this to be an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1424490-2013-00001 |
| MDR Report Key | 3034813 |
| Report Source | 00 |
| Date Received | 2013-03-28 |
| Date of Report | 2013-02-28 |
| Date of Event | 2013-02-28 |
| Date Facility Aware | 2013-02-28 |
| Report Date | 2013-02-28 |
| Date Mfgr Received | 2013-02-28 |
| Date Added to Maude | 2013-04-18 |
| 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 | 3 |
| 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 207, INC. |
| Manufacturer Street | 14414 DETROIT AVE. STE. 310 |
| Manufacturer City | LAKEWOOD OH 44107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44107 |
| 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 | 2013-03-28 |
| Model Number | PURESOM RUBY CHIN STRAP, MED |
| Catalog Number | TMS-09M |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-03-28 |