Model Number 70011 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)
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Event Date 02/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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The patient denied any previous drug allergies pre-operatively and upon presentation with symptoms postoperatively, denied being allergic to mometasone furoate (nasonex).However, the patient subsequently remembered that he had previously experienced edema when using nasonex.Based on the clinical presentation, the resolution of the symptoms upon removal of the implants and the additional medical history indicative of an allergy to mometasone furoate, it is the treating physician's medical opinion that the patient suffered an allergic reaction to the mometasone furoate on the surface of the implants.The instructions for use states that the use of the sinus implant is contraindicated in patients with suspected or confirmed intolerance to mometasone furoate.The patient's weight is not known to the manufacturer.The device was not available for evaluation as it was not returned to the manufacturer.The following is being provided as this device is a combination product: name: propel; dose, frequency & route used: (1) 370 ug implant; diagnosis for use: sinus surgery.Combination product -yes.
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Event Description
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Patient underwent revision sinus surgery which included bilateral total ethmoidectomy and maxillary antrostomy followed by placement of 1 drug-eluting sinus implant into each ethmoid sinus.Patient presented post op day 3 and 4 with bilateral periorbital edema, severe pain and blurred vision.Post op day 4, ct scan conducted showed no damage to orbit and no infections.Based on the clinical picture, negative ct scan and physical exam findings, the physician concluded that the most likely cause of the patient's symptoms was an allergic reaction to the implants and removed both.The patient's bilateral ocular edema was significantly reduced within 2 hours of the removal.The physician reports during his follow-up visit, the patients' symptoms were completely resolved.
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Event Description
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Patient underwent revision sinus surgery which included bilateral total ethmoidectomy and maxillary antrostomy followed by placement of 1 drug-eluting sinus implant into each ethmoid sinus.Patient presented post op day 3 and 4 with bi-lateral periorbital edema, severe pain and blurred vision.Post op day 4 ct scan conducted showed no damage to orbit and no infections.Based on the clinical picture, negative ct scan and physical exam findings, the physician concluded that the most likely cause of the patient's symptoms was an allergic reaction to the mometasone furoate on the suface of the implants and removed both.The patient's bilateral periorbital edema was significantly reduced within 2 hours of removal.The physician reports during his follow-up visit, the patients' symptoms were completely resolved.
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Manufacturer Narrative
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Correction to describe event or problem (b5).Initial report: the patient's bilateral occular edema was significantly reduced within 2 hours of removal.Corrected report description: the patient's bilateral periorbital edema was significantly reduced within 2 hours of removal.Additionally clarified the allergic reaction to the implants was to the mometasone furoate on the surface of the implants.Reference 3008301917-2017-00006 for second implant of bilateral case.
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Search Alerts/Recalls
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