MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-27 for HALO 02-000 manufactured by Core Labs, Llc.
[3056421]
Unwanted corrosion appeared on the device, which may cause (caused) structural damage to the unit. Further investigation is required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026699 |
| MDR Report Key | 2720773 |
| Date Received | 2012-08-27 |
| Date of Report | 2012-08-10 |
| Date of Event | 2012-08-06 |
| Date Added to Maude | 2012-09-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALO |
| Generic Name | OVERHEAD TUBE HOLDER |
| Product Code | IYB |
| Date Received | 2012-08-27 |
| Model Number | 02-000 |
| ID Number | 0410 0004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORE LABS, LLC |
| Manufacturer Address | 3720 S LIPAN ST UNIT A ENGLEWOOD CO 80110 US 80110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-27 |