MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-09 for PONTO manufactured by Oticon Medical Ab.
| Report Number | 3007367732-2020-00015 |
| MDR Report Key | 9804762 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-01 |
| Date Facility Aware | 2020-02-28 |
| Report Date | 2020-02-28 |
| Date Reported to Mfgr | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-09 |
| 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 PATRIK L |
| Manufacturer Street | DATAV |
| Manufacturer City | ASKIM, 436 32 |
| Manufacturer Country | SW |
| Manufacturer Postal | 436 32 |
| Manufacturer G1 | OTICON MEDICAL AB |
| Manufacturer Street | DATAV |
| Manufacturer City | ASKIM, 43632 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43632 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PONTO |
| Generic Name | BONE ANCHORED HEARING IMPLANT |
| Product Code | MAH |
| Date Received | 2020-03-09 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTICON MEDICAL AB |
| Manufacturer Address | DATAV?GEN 37 B ASKIM, 43632 SW 43632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |