MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-11-14 for UNKNOWN manufactured by Carefusion, Inc.
[59788607]
Initial emdr submission: multiple attempts have been made to gather additional information from the customer regarding the product code used, patient demographics, and what treatment was provided if any to the patient. To date no information has been made available from the customer. Cfn marketing has been contacted and has confirmed that the alleged product could be one of the following codes 777040xs, s, s/m, m, l, and xl. However, we are unable to confirm the actual product code without the customers response. Marketing has provided the customer with training resources regarding the proper use of the cpap headgear to eliminate straps one and three from being too tight. If any further information becomes available a supplemental submission will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59788608]
Customer reported the following "we have been having issues with the cpap headgear. Babies heads are becoming misshapen with overlapping cranial sutures".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2016-00259 |
| MDR Report Key | 6099062 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-11-14 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2016-10-20 |
| Date Added to Maude | 2016-11-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | CERRADA V NO. 85., PARQUE INDUSTRIAL MEX |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT |
| Product Code | NHJ |
| Date Received | 2016-11-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-14 |