MAUDE Adverse Event Report: ABIGO MEDICAL AB OTOVENT; MIDDLE EAR DECOMPRESSOR, POSITIVE PRESSURE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sinus Perforation (2277)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Reference to the concerned article (case report) is millington aj, perkins v, salam ma.Pneumocephalus and orbital emphysema associated with the use of an autoinflation device: a unique case report and review of the literature.J laryngol otol 2019; 133:157-160.Https://doi.Org/10.1017/s0022215119000070.Stated event date: according to general instructions - for form fda 3500a medwatch (for mandatory reporting), the event date is recorded as the date of the journal article.According to the article the event occurred late 2016.(b)(4).

Event Description

This incident came to abigo's awareness during an internal systematic literature review.A case report on a (b)(6)-year-old woman using otovent for her eustachian tube dysfunction with a severe adverse event was described.The woman had undergone endoscopic sinus surgery in 2003, including septoplasty, uncinectomy, antrostomy and ethmoidectomy.Immediately after use of otovent, the woman developed headache, nausea and photophobia.She presented to the emergency department and was diagnosed with pneumocephalus and orbital emphysema, which resolved after hospital admittance for three days.She was treated with a pneumococcal vaccine, broad-spectrum antibiotics and analgesics.Follow up at the out-patient clinic six weeks later revealed no residual symptoms.

Manufacturer Narrative

The article author was contacted to get further information regarding the event, such as batch and location of the device.The reply from the author states that this information is not available but he suspects that the device has been discarded.However, there is nothing in the available information that indicates that there has been any malfunction of the device.The harm has been risk assessed and it has been concluded that although serious in nature, the harm is very rare.The otovent product has been extensively used and this is the only report describing pneumocephalus during use of otovent.It is also concluded that the increased pressure generated while sneezing, performing the valsalva etc.Usually exceeds the pressure obtained by using otovent.The risk benefit balance was reviewed and it was concluded that the benefits to the patient with the use of otovent outweighs any individual residual risk or any combination of residual risks.Otovent is considered to be a safe medical device.The outcome of the risk management work is that the warnings and precautions-section of the instruction for use (ifu) will be updated with the following text: "if you have had sinus surgery, consult your physician before using otovent." "if you experience severe headache, severe dizziness, sensitivity to light, and/or nausea in connection with using otovent, immediately stop treatment and consult your physician." the updated instruction for use is planned to be implemented as part of abigo's medical device regulation (mdr) project for otovent with a deadline of may 2020.Based on the risk assessment made on the subject case no field actions are taken.Abigo will continue to monitor similar incidents.

• Brand Name: OTOVENT
• Type of Device: MIDDLE EAR DECOMPRESSOR, POSITIVE PRESSURE
• Manufacturer (Section D): ABIGO MEDICAL AB; ekonomivägen 5; askim, SE-43 6 33; SW SE-436 33
• MDR Report Key: 9157588
• MDR Text Key: 165801262
• Report Number: 8043991-2019-00002
• Device Sequence Number: 1
• Product Code: MJV
• Combination Product (y/n): N
• PMA/PMN Number: K920840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRA-NASAL STEROID SPRAY; NASAL DECONGESTANT
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR