MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-07-01 for DS ANTERIOR 1.5T 9896-030-23954 manufactured by Invivo Corporation.
[48647586]
Event is under investigation and updates will be provided on a later date. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[48647587]
A male patient was positioned head first supine and scanned for pelvis examination using the ds anterior 1. 5t coil. The patient experienced a heating sensation and 2nd degree burns resulting in blisters ( approx. 2cm x 2cm) on the inside of both inner thighs.
Patient Sequence No: 1, Text Type: D, B5
[59473587]
Based on the provided information and test performed on site, there is no indication of a malfunction of the coil used that contributed. The injuries on the inside of the patient? S inner thighs are consistent with injuries caused by so called skin-to-skin contact. Although padding was used between the legs this could not prevent the upper inner thighs from touching. It was stated that there was potential for skin-to-skin contact close to the affected area. Furthermore, 3 scans on high sar level were administered that may have contributed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2016-00001 |
| MDR Report Key | 5764841 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-28 |
| Date Mfgr Received | 2016-06-01 |
| Device Manufacturer Date | 2014-07-19 |
| Date Added to Maude | 2016-07-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KENNETH REVENNAUGH |
| Manufacturer Street | 3545 SW 47TH AVE |
| Manufacturer City | GAINSVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer G1 | PHILIPS HEALTHCARE - INVIVO DIAGNOSTIC IMAGING |
| Manufacturer Street | 3545 SW 47TH AVE |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32608 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DS ANTERIOR 1.5T |
| Generic Name | DS ANTERIOR 1.5T |
| Product Code | MOS |
| Date Received | 2016-07-01 |
| Model Number | 9896-030-23954 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORPORATION |
| Manufacturer Address | 3545 SW 47TH AVE GAINSVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-01 |