MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-04-16 for 8CH SHOULDER COIL 1, 5T IRF 453530283041 manufactured by Invivo Corp..
[17463867]
During a scanning process, the patient was positioned supine head first in a philips ingenia 1. 5t system. A shoulder coil 8ch 1. 5t was used to perform a shoulder examination. After the examination, a second degree blister of 3 by 4 centimeter was observed on the right lower arm.
Patient Sequence No: 1, Text Type: D, B5
[17758505]
(b)(4). Evaluation method, results, conclusions: the investigation is still ongoing on this event. When the investigation is completed, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2013-00001 |
| MDR Report Key | 3069619 |
| Report Source | 08 |
| Date Received | 2013-04-16 |
| Date of Report | 2013-04-11 |
| Date of Event | 2013-02-28 |
| Date Mfgr Received | 2013-03-18 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2013-04-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KENNETH REVENNAUGH, DIRECTOR |
| Manufacturer Street | 3545 SW 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523360010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 8CH SHOULDER COIL 1, 5T IRF |
| Generic Name | NONE |
| Product Code | MOS |
| Date Received | 2013-04-16 |
| Model Number | 453530283041 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORP. |
| Manufacturer Address | 3545 SW 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-16 |