MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-24 for DALE BENDABLE ARMBOARD H84106501 manufactured by Dale.
[52921119]
Patient Sequence No: 1, Text Type: N, H10
[52921120]
Teenage patient noted to have blister on his hand after mri. Patient stated that while in mri yesterday, he felt his hand burning underneath the armboard securing his arterial line (dale bendable armboard). Upon exiting the mri, he said he told staff his hand was very warm and it was attributed to receiving iv contrast. Pt took off arm board upon return to surgical icu and noticed a burn which then blistered. The patient had a quarter-sized intact serous fluid filled blister on back of hand. The patient was seen by the medical team. The team unroofed the blister and covered with a bandaid. The armboard is listed as an mri conditional product. The conditions for use in mri were met as the exam was 1. 5t and within other specifications. This armboard has been placed on our list of products that should not go into mri suite. Patient had multiple skin abrasions due to trauma sustained in an mva prior to admission that may have caused or contributed to the burn as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5899681 |
| MDR Report Key | 5899681 |
| Date Received | 2016-08-24 |
| Date of Report | 2016-08-18 |
| Date of Event | 2016-08-12 |
| Report Date | 2016-08-18 |
| Date Reported to FDA | 2016-08-18 |
| Date Reported to Mfgr | 2016-08-18 |
| Date Added to Maude | 2016-08-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | DALE BENDABLE ARMBOARD |
| Generic Name | ARMBOARDS |
| Product Code | NOD |
| Date Received | 2016-08-24 |
| Catalog Number | H84106501 |
| ID Number | LARGE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DALE |
| Manufacturer Address | 7 CROSS ST P.O. BOX 1556 PLAINVILLE MA 02762 US 02762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-24 |