MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-28 for ARM-IR FOR TOSHIBA 8508/8708 TABLE TOP ARMIR04 manufactured by Tidi Products, Llc.
[87720296]
Age/date of birth, weight: ni. (b)(4): this is the initial report. Tidi products has been in contact with the initial reporter and is in the process of obtaining further information and will be investigating. Note: it was reported by the patient care manager that after the procedure the patient reported soreness, bruising, redness, and swelling in the area of the right forearm lateral aspect above the elbow. Customer not responsive.
Patient Sequence No: 1, Text Type: N, H10
[87720297]
The patient care manager recently experienced issues with patient injury during a heart catheterization procedure with the use of the arm-ir04.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825560-2017-00077 |
| MDR Report Key | 6902855 |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2017-08-28 |
| Device Manufacturer Date | 2014-07-14 |
| Date Added to Maude | 2017-09-28 |
| 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 | EWELINA ROG |
| Manufacturer Street | 14241 N. FENTON RD |
| Manufacturer City | FENTON MI 48430 |
| Manufacturer Country | US |
| Manufacturer Postal | 48430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARM-IR FOR TOSHIBA 8508/8708 TABLE TOP |
| Generic Name | TABLE, RADIOLOGIC |
| Product Code | KXJ |
| Date Received | 2017-09-28 |
| Model Number | ARMIR04 |
| Catalog Number | ARMIR04 |
| Lot Number | 554313 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS, LLC |
| Manufacturer Address | 14241 FENTON RD FENTON MI 48430 US 48430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-28 |