MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for AMBU PERFIT COLLAR 19-9007 manufactured by Corflex.
[121487572]
Middle aged patient collapsed on the ground in the hospital unit. A code head bleed and a code blue were called and the patient was placed in cervical collar, placed on a stretcher, and transferred rapidly to the intensive care unit (icu). The patient remained in the icu for treatment cardiac arrest secondary to an acute pulmonary embolus. He remained in a collar. Several days later, the patient complained of mild pain from an abrasion on the back of his head. The wound was assessed, and no drainage was noted. The wound nurse was consulted. The wound nurse was consulted for two areas of redness, on the patient's shoulder and head, likely related to the c-spine collar. Both areas appeared to be unstageable. The presumed underlying etiology as pressure related to the rigid spinal collar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7901376 |
| MDR Report Key | 7901376 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-08-07 |
| Report Date | 2018-09-07 |
| Date Reported to FDA | 2018-09-07 |
| Date Reported to Mfgr | 2018-09-24 |
| Date Added to Maude | 2018-09-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMBU PERFIT COLLAR |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2018-09-24 |
| Model Number | 19-9007 |
| Catalog Number | 19-9007 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORFLEX |
| Manufacturer Address | 669 EAST INDUSTRIAL PARK MANCHESTER NH 03109 US 03109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-24 |