MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-16 for NASONEB NASAL NEBULIZER 5070 manufactured by Medinvent, Llc.
[55004905]
It is unknown if this is a pre-existing condition. We do not believe the nasoneb and n-acetylcysteine contributed to the loss of sense of smell as it continued to get worse after she discontinued use of the nasoneb and medication. The history is inconsistent with the report of a few weeks of use as the patient refilled the prescription after 30 days. It does not appear that the other medications would contribute to hyposmia. Mild bleeding upon use is normal at first use when there is crusting or infection causing the nose to bleed. N-acetylcysteine has been associated with pain on delivery and mucosal bleeding, the labeling for the commercial product stops short of calling out a causative relationship. The patient changed doctors and the new ent, (b)(6), prescribed intranasal corticosteroids. He suspects that the reduction in sense of smell is from inflammation, this is possibly due to the withdrawal of the mucinex d from her regimen. The n-acetylcysteine was compounded at (b)(6), lot numbers 05172016@2, 06162016@59, 02122016@33. The bud is 11/3/2016. The dosing is 200 mg. Bid/tid. The leader brand saline lot number is unknown. The bud date on the saline is 1 year from dispensing according to the pharmacist. Other medications included: lexapro, valtrex, milaxacam, vagisim. Dosage are unknown. The delay in reporting was due to the length of time it took to obtain a webtrader account. Device functioned properly.
Patient Sequence No: 1, Text Type: N, H10
[55004906]
(b)(6) reports that a patient complains of a reduced sense of smell after a few weeks of use with n-acetyl cysteine. Patient had discontinued use for 3 weeks. She stated that she had noticed a reduction in smell after the first few doses and it became more noticeable over time. Patient was prescribed n-acetylcysteine for chronic congestion after long term use of mucinex-d (guaifenesin and pseudoephedrine) which was concomitantly discontinued with the initiation of n-acetylcysteine. N-acetylcysteine was compounded in a dry powder formulation (loxasperse, pcca) and provided leader brand saline wound wash by (b)(6) pharmacy. According to the label, there are no preservatives in the saline wash. Patient complained of pain for 30-60 minutes after using the device and irritation of the nasal passages. Patient noted blood in the cup and when blowing her nose after therapy which was self-limiting. Patient indicated no history or viral infection. It is unclear why then she is on valtrex. No reported history of surgery. She switched doctors and the new ent, (b)(6), prescribed intranasal corticosteroids. He suspects that the reduction in sense of smell is from inflammation, this is possibly due to the withdrawal of the mucinex d from her regimen. Questions for the md: endoscopic presentation - was there anything remarkable with respect to the hyposmia? Crusting, open sores? What location? Did he find any evidence of why she was having bleeding? Did the olfactory cleft appear remarkable? No remarkable findings with endoscopic exam. No open sores, crusting, evidence of bleeding or any sign of injury to nasal passages. Culture negative for infection. Does he believe the n-acetylcysteine contributed to the hyposmia? Why or why not? Does he believe the nasoneb contributed to the hyposmia? Why or why not? He is unsure as to what could be the causative factor. It is an unexpected reaction with therapies being used. Does he believe the discontinuation of mucinex-d contributed to the hyposmia? Why or why not? Does he believe the n-acetylcysteine was an appropriate prescription for her condition? Why or why not? In his opinion, what did he think was the underlying cause for the hyposmia and the timing of its onset? Unclear. He did not believe the nasoneb and n-acetylcysteine contributed. What corticosteroid is he prescribing and what is the route of administration and the administration device? Flonase. This is an continuation of a prescription. It is not clear why the patient initially stopped taking this. Patient has not followed up with pharmacy since initial conversation in (b)(6). Currently unaware if the condition has subsided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1648287-2016-00001 |
| MDR Report Key | 5957806 |
| Date Received | 2016-09-16 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-07-18 |
| Date Mfgr Received | 2006-07-18 |
| Date Added to Maude | 2016-09-16 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM FLICKINGER |
| Manufacturer Street | 1133 MEDINA RD. STE 500 |
| Manufacturer City | MEDINA OH 44256 |
| Manufacturer Country | US |
| Manufacturer Postal | 44256 |
| Manufacturer Phone | 3302470921 |
| Manufacturer G1 | MEDINVENT, LLC |
| Manufacturer Street | 1133 MEDINA RD. STE 500 |
| Manufacturer City | MEDINA OH 44256 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NASONEB NASAL NEBULIZER |
| Generic Name | NASAL NEBULIZER |
| Product Code | JPW |
| Date Received | 2016-09-16 |
| Model Number | 5070 |
| Catalog Number | 5070 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDINVENT, LLC |
| Manufacturer Address | 1133 MEDINA RD. STE 500 MEDINA OH 44256 US 44256 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-09-16 |