MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for HIRES? ULTRA 3D IMPLANT CI-1601-05 NA manufactured by Advanced Bionics, Llc.
[185892294]
Advanced bionics considers the investigation into this reportable event as closed. The recipient's swelling resolved. The recipient resumed device use. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
[185892295]
In (b)(6) 2020, the recipient reportedly experienced an infection and swelling over the implant site. The recipient's infection is not device related. The recipient was prescribed 10 days of antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006556115-2020-00154 |
| MDR Report Key | 9908195 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-02 |
| Device Manufacturer Date | 2019-02-28 |
| Date Added to Maude | 2020-03-31 |
| 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 | LACEY MCDONALD |
| Manufacturer Street | 28515 WESTINGHOUSE PLACE |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIRES? ULTRA 3D IMPLANT |
| Generic Name | COCHLEAR IMPLANT |
| Product Code | MCM |
| Date Received | 2020-03-31 |
| Model Number | CI-1601-05 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED BIONICS, LLC |
| Manufacturer Address | 28515 WESTINGHOUSE PLACE VALENCIA CA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |