MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-07-09 for SENSE HEAD COIL 1.5T 8 CH 4522-132-14165 manufactured by Invivo Corp.
[4628203]
Philips received a report of a heating incident. A patient was scanned on an achieva mr system with the sense head coil. Blistering (2nd degree) was noted after the examination at the upper rear triceps area of the patient's left arm. The total size of the blisters is reported to be covering one and a half square inch.
Patient Sequence No: 1, Text Type: D, B5
[12070328]
(b)(4). The investigation is still on going on this event. When the investigation is completed a follow up report will be send to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2014-00002 |
| MDR Report Key | 3970972 |
| Report Source | 08 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-07-08 |
| Date of Event | 2014-06-06 |
| Date Mfgr Received | 2014-06-10 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2014-08-01 |
| 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 S.W. 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 | SENSE HEAD COIL 1.5T 8 CH |
| Generic Name | NONE |
| Product Code | MOS |
| Date Received | 2014-07-09 |
| Returned To Mfg | 2014-06-20 |
| Model Number | 4522-132-14165 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORP |
| Manufacturer Address | 3545 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-09 |