MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,foreign report with the FDA on 2017-02-23 for OTOVENT manufactured by Abigo Medical Ab.
[68116954]
Patient reported to have a medical history of previous acute otitis media with perforation of the ear drum, longstanding serous otitis media treated with grommets and the reoccurrence of new serous otitis media. Due to earlier perforations of the ear drum and treatment with grommets reported, the patient may be considered at greater risk of perforations. The case is considered to be of minor to moderate severity that could result in injury or impairment possibly requiring professional medical intervention.
Patient Sequence No: 1, Text Type: N, H10
[68116955]
The device had been used as directed for about 3-4 days, when the user did about 2 puffs and suddenly cried out in pain and holding his right ear. The reporter states a specialist nurse has concluded a perforation of the right eardrum through otoscope investigation.
Patient Sequence No: 1, Text Type: D, B5
[96862981]
Patient reported to have a medical history of previous acute otitis media with perforation of the ear drum, longstanding serous otitis media treated with grommets and the reoccurrence of new serous otitis media. Due to earlier perforations of the ear drum and treatment with grommets reported, the patient may be considered at greater risk of perforations. The case is considered to be of minor to moderate severity that could result in injury or impairment possibly requiring professional medical intervention. Additional information in follow up report: the patient has been reported via professional healthcare to be recovered.
Patient Sequence No: 1, Text Type: N, H10
[96862982]
The device had been used as directed for about 3-4 days, when the user did about 2 puffs and suddenly cried out in pain and holding his right ear. The reporter states a specialist nurse has concluded a perforation of the right eardrum through otoscope investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043991-2017-00001 |
| MDR Report Key | 6352553 |
| Report Source | CONSUMER,DISTRIBUTOR,FOREIGN |
| Date Received | 2017-02-23 |
| Date of Report | 2017-02-21 |
| Date of Event | 2017-01-06 |
| Date Mfgr Received | 2017-02-08 |
| Date Added to Maude | 2017-02-23 |
| 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 ANNICA CORB |
| Manufacturer Street | EKONOMIV |
| Manufacturer City | ASKIM, SE-.43633 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-.43633 |
| Manufacturer Phone | 31 7484950 |
| 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 | OTOVENT |
| Product Code | MJV |
| Date Received | 2017-02-23 |
| Returned To Mfg | 2017-03-09 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIGO MEDICAL AB |
| Manufacturer Address | EKONOMIVAGEN 5 ASKIM, SE-43633 SW SE-43633 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-23 |