MAUDE Adverse Event Report: ABIGO MEDICAL AB OTOVENT; MIDDLE EAR VENTILATOR

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

Patient Problems Nausea (1970); Pain (1994); Tinnitus (2103); Vertigo (2134); Dizziness (2194); Disability (2371); No Code Available (3191)

Event Date 09/01/2014

Event Type  Injury  

Event Description

(b)(4) is a serious, medically unconfirmed case reported by a consumer in (b)(6) to (b)(4) on (b)(6) 2015.(b)(4) forwarded the information to abigo medical ab the same day.Follow-up information was received from the consumer on (b)(6) 2015 including a letter from a specialist physician (neuro-otologist) to the consumer's gp on (b)(6) 2015.The report concerns a (b)(6) female consumer who experienced that her ear "blew through" leading to a possible bitaleral perilymph fistula when using the otovent device.No concomitant medications were reported.The neuro-otologist describes that the consumer had a complex history which essentially started in (b)(6) 2014 following in transanal saline rinsing for her rhino-sinusitis.Following the nasal rinse the left ear became acutely painful and muffled with fluctuations in pressure and pain radiating into the jaw.It was noted that the consumer had some fluid behind the tympanic membrane on the left side and therefore was recommended to use otovent and valsalva maneuver for a fortnight.The symptoms in the head and ear gradually settled at the end of (b)(6) whilst using the otovent and valsalva maneuver the right ear had a sudden sharp pressure sensation with immediate high pitched tinnitus and sevete otalgia.The following day the consumer developed severe rotary vertigo with nausea and retching and was unwell for the best part of 10 days.The neuro-otologist states in the letter that the consumer has been left with chronic imbalance and diminished hearing as well as intrusive tinnitus, difficulty focusing.The consumer describes that she had fluid trapped in her left middle ear space after a saline nasal sinus rinse, which was performed once.Before that, she had no ear problems with perfect hearing and balance.Five weeks after the fluid was trapped she started to use otovent.One evening when she was using the otovent she suddenly felt one of the ears "blow through" and suddenly developed incredible ear pain, vertigo, very poor balance, dizziness, nausea, tinnitus, ear fullness and further (not specified) symptoms.She had used otovent for 10 days, 3 times a day, before the event.She inflated the otovent balloon to the size of a grapefruit as instructed.The product was thrown away after the event, so the batch number and expiry date cannot be retrieved.Two days after the event she went back to her gp who based on her history and symptoms decided it was likely she had a condition called bilateral perilymph fistula with damage to the inner ears and destruction of the oval and round windows.Both ears were damaged.At the time of the report the consumer states that her symptoms are worse than ever.She is a very much disabled and bed bound 23 hours/day.She cannot walk and has to use walking sticks.She has had to leave her job and live with her parents as a result.According to the consumer the neuro-otologist will perform inner ear surgery on her during june 2015.The consumer has promised to forward a report from the neuro-otologist after the ear surgery.

Manufacturer Narrative

For the preliminary analysis two physicians have assessed the case, an ent specialist and the manufacturer's safety physician.Follow-up is on-going.Assessment by ent specialist: it is not unlikely that an inner ear problem has occurred in combination with otovent autoinflation and valsalva's maneuver.Perilymphatic fistulae have been reported to have occurred after valsalva's maneuver (pressure up to 1000mm water), nose blowing (pressure up to 1000mm water), sneezing (pressure up to 1500mm water), air flight (pressure up to 2500mm water), scuba diving (pressure up to 6000mm water).Otovent autoinflation provides a pressure of up to 600mm water.Otovent is indicated in situations with negative middle ear pressure, eustachian tube dysfunction (etd) and secretory otitis media (som).The patient had fluid in the left middle ear for 5 weeks following a nasal saline water rinse.If the patient had etd then saline water from a nasal rinse would not be able to pass through the eustachian tube to the middle ear.Most likely the patient had an open eustachian tube, and in this case otovent is not indicated.In this case a simple sneeze or nose blowing could have caused the trauma.If the patient had saline water in the middle ear after a nasal rinse, this potentially infected water could have caused a labyrinthitis with similar symptoms.Assessment by the manufacturer's safety physician: bilateral perilymph fistula is reported after the use of otovent.Perilymph fistula can be caused by head trauma involving a direct blow to the head or in some cases a "whiplash" injury.Other causes include ear trauma, objects perforating the eardrum, or "ear block" on decent of an airplane of scuba diving.Fistulas may also develop after rapid increases in intracranial pressure, such as may occur with weightlifting or childbirth.In this case, the patient had problems with fluid in the left middle ear after using saline nasal sinus rinse and used otovent and valsalva's manoeuvre as treatment for the fluid in the middle ear.She had used otovent for 10 days before the reported event.A professor in otology/neuro-otology has confirmed the vestibular symptoms and examined the drumheads that were intact.He suspected a possible perilymph leak in the left and then in the right ear and further examinations incl full vestibular function tests, ct, etc were recommended by the otologist in (b)(6) 2015.Information regarding medical history, concomitant medication and results from the recommended examinations is missing.Based on currently available information and that the symptoms occurred during the use of otovent, a causal relationship cannot fully be excluded.However, other possible explanations must be considered.

Manufacturer Narrative

In (b)(6) 2015 the consumer underwent inner ear surgery: right permeatal tympanotomy.According to the records from the surgery a perilymphatic leak was probably/possibly present.In (b)(6) 2015 the consumer went for a follow-up visit to the clinic and was considered to be healing very well.She then described symptoms of a feeling of pulling to the right or falling to the right, particularly when walking, but was reassured that there are good chances of getting back to normal.In (b)(6) 2015 a full vestibular assessment was performed that showed evidence of reduced functional vestibular ocular reflex, as well as visual vertigo and reduced balance strategies.Outpatient physiotherapy sessions were planned.The current report does not change the risk-benefit assessment of otovent, which remains favorable.The safety profile of the product is continuously monitored and assessed.

Event Description

Reference is made to the initial report 8043991-2015-00001.

• Brand Name: OTOVENT
• Type of Device: MIDDLE EAR VENTILATOR
• Manufacturer (Section D): ABIGO MEDICAL AB; ekonomivagen 5; askim, SE-43 633; SW SE-43633
• Manufacturer (Section G): ABIGO MEDICAL AB; vapenvagen 1; askersund, SE-69 633; SW SE-69633
• Manufacturer Contact: annica corbé ; ekonomivagen 5; askim, SE-43-633 ; SW SE-43633 ; 6317484950
• MDR Report Key: 4873904
• MDR Text Key: 6048094
• Report Number: 8043991-2015-00001
• Device Sequence Number: 1
• Product Code: MJV
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K920840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor,consumer,distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• 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: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 27 YR