MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-21 for ANEURYSM CLIP manufactured by Unk.
[100892920]
The reporter states the pt came in for a routine mri and had stated that she had no devices implanted as well as no brain and heart surgeries prior. Once the pt laid down on the mri table, the mri technologist went to get ear plugs and upon return discovered the pt unresponsive on the table. The technologist rolled out the bed with the pt in it and activated the emergency response code and that's when the emergency doctors came. The drs found a carotid pulse and called for a ct study where they found the pt had an aneurysm clip placed and a brain bleed in a different location in the brain. The reporter had the neurological team observe the case and didn't believe the clip had anything to do with the event.
Patient Sequence No: 1, Text Type: D, B5
[114694435]
Add'l info received from reporter for report mw5075442, on 07/13/2018. Reporter stated she would like her company name ((b)(6)) included in her reporter info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075442 |
| MDR Report Key | 7289224 |
| Date Received | 2018-02-21 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-02-16 |
| Date Added to Maude | 2018-02-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANEURYSM CLIP |
| Generic Name | ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2018-02-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2018-02-21 |