MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-04 for OTOVENT manufactured by Abigo Medical Ab.
| Report Number | 8043991-2019-00002 |
| MDR Report Key | 9157588 |
| Date Received | 2019-10-04 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-10-25 |
| Date Added to Maude | 2019-10-04 |
| 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 | MS. EVA BRUNHAGE |
| Manufacturer Street | EKONOMIV |
| Manufacturer City | ASKIM, SE-436 33 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-436 33 |
| Manufacturer G1 | ABIGO MEDICAL AB |
| Manufacturer Street | VAPENV |
| Manufacturer City | ASKERSUND, SE-69633 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-69633 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OTOVENT |
| Generic Name | MIDDLE EAR DECOMPRESSOR, POSITIVE PRESSURE |
| Product Code | MJV |
| Date Received | 2019-10-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIGO MEDICAL AB |
| Manufacturer Address | EKONOMIV?GEN 5 ASKIM, SE-436 33 SW SE-436 33 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2019-10-04 |