MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08,distributor report with the FDA on 2015-02-03 for SENSE SHOULDER COIL 1.5T 4CH 9896-030-13432 manufactured by Invivo Corp.
[5344103]
A female patient was positioned head first supine and scanned with the shoulder coil for an examination of the left shoulder. The patient stated she felt a tingling sensation at the top the left shoulder. After the examination a small bump was observed that developed into a 4cm size blister on top of the left shoulder.
Patient Sequence No: 1, Text Type: D, B5
[12911594]
(b)(4). Method, results, conclusions: the investigation is still ongoing on this event. When the investigation is completed a f/u report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[31807955]
(b)(4). No definite root cause for the injury as sustained by the patient could be determined. The most likely root case is a combination of the technician not using any patient ventilation in combination with 8 consecutive scans with high sar values with-out pauses to allow for the patient body to cool down. Product was not returned to the manufacturer, the customer has an agreement with a third party service organization which was unable to return the product to invivo.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2015-00004 |
| MDR Report Key | 4487167 |
| Report Source | 08,DISTRIBUTOR |
| Date Received | 2015-02-03 |
| Date of Report | 2015-01-30 |
| Date of Event | 2015-01-09 |
| Date Mfgr Received | 2015-01-26 |
| Date Added to Maude | 2015-02-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KENNETH REVENNAUGH, DIR |
| Manufacturer Street | 3545 S.W. 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523360010 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSE SHOULDER COIL 1.5T 4CH |
| Generic Name | CH SHOULDER |
| Product Code | MOS |
| Date Received | 2015-02-03 |
| Model Number | 9896-030-13432 |
| 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 CORP |
| Manufacturer Address | 3545 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-03 |