[2098356]
Summary: custom molded silicone earplugs marketed by (b)(4) did not cure correctly leaving a 9. 72mm x 5. 20 mm x 3. 45mm piece of silicon material in the left ear canal resulting in a >90% obstruction and hearing loss. The product was purchased on (b)(6) 2011 from the (b)(6) sporting goods on-line store. The (b)(4) rep stated the product is not a medical device and therefore, does not need to adhere to any fda regulations. Per (b)(6) of the fda the product is a classii medical device. Detail: on (b)(6) 2011, after reading the mfr's instructions, i prepared the white and orange silicone material by separating it into 4 equal portions (2 white, 2 orange). The material was placed in the containers provided by the mfr. To ensure that the curing time could be counted correctly, prior to mixing the material, a timer was set for the 10 mins called out by the instructions. As per the instructions, one portion each of the white and orange silicon was kneaded for approx 45 secs until material was a uniform color. Per instructions, material was rolled into a ball and while looking in a mirror i placed it in the left ear. I pressed on the center and folded the material until a good seal was achieved. The excess material (approx half of what i started with) was removed and set aside. The 10 mins timer was started. The remaining material was rolled into a ball and the process repeated for the right ear. A second 10 mins timer was started. During curing, i sat in an upright position and did not move my jaw (no talking, chewing, yawning etc). At the end of the first 10 mins, i checked the consistency of the silicon and found the material had not set. Since the 10 mins curing time was noted as a minimum, i left the material in my ears for a total time of 60 mins checking on the consistency at 10 mins intervals. At the end of 60 mins, i checked the silicone to find it was still very soft. Since the silicon had not cured i attempted to remove the earplugs starting with the left ear. Per instruction, i started from the top of my ear and pulled down to carefully removed the silicone. The portion of the material that extended into ear canal broke off, leaving my ear canal plugged. I used the same process for the right ear with a similar result. I rolled it into a ball and placed it on top of one of the closed product containers. Using a cotton swab, i attempted to remove the silicon from both ears. I was able to remove the majority of the silicon from the right ear, but the portion that broke off in the left ear could not be removed the hearing in my left ear was significantly reduced and it felt as if there was still something in the ear. My husband visually checked both of my ears and could not see anything. When i returned from cleaning my ears, i noticed that the material i had rolled into a ball and placed on the product container appeared as if it had melted and was now a smooth dome shaped disk. Periodically for the next four hours i reshaped the material, placed it on the closed product container and watched it melt. Each time the material held its shape for a little longer. It took four hours for the material to cure enough to hold the shape of a ball. Although the material was firm, i was able to break it into two pieces. On (b)(6) 2011 at approx 7 am, i checked the silicon pieces to find they were very hard. The same held true for the silicone in my left ear. The hearing in the left ear was almost completely gone and it felt as if i had something very hard in the ear canal. At approx 3:30 pm, my husband check my ears using an otoscope in the left ear, orange silicone, was observed blocking about 90% of left ear canal. In the right ear small amounts of silicone were seen but could not tell if the canal was blocked. At approx 4 pm, i contacted the mfr and the call was forwarded to (b)(6), industrial inside sales manager. I told (b)(6) of the incident and asked her what i should do. She asked me if i had tried using a cotton swab to remove the material stating that when this happens the material can typically be removed that way. I told her i had tried this and it did not work. (b)(6) then stated i should go to an urgent care clinic or an ent specialist to have the material removed. At approx 5 pm, i presented to the cupertino medical group for treatment. Physician's assistant (b)(6) provided treatment. Initially (b)(6) was unable to see any obstruction in either ear. Upon repositioning, the otoscope deeper into the left ear canal, he observed the orange colored material. Using a long scissor like surgical tool (b)(6) attempted to remove the obstruction. It took several attempts and a fair amount of difficulty to remove the obstruction as it was deep in the ear canal, hard to access and extremely painful. Topical anesthetic could not be used as it would make the material slippery. (b)(6) removed a piece of hard orange silicone measuring 9. 72 mm x 5. 20 mm x 3. 45 mm and similar in shape to the image shown in the (b)(4) ifu of the "properly formed earlplug" identified as "partially extends into the ear canal". To address the immediate pain from the procedure, lydocain in solution was applied. No obstruction was found in the right ear. To prevent infection, ear drops of neomycin and polymyxin b sulfates and hydrocortisone optic in suspension were prescribed with a dosage of 4 drops in the left ear 3 times a day for 5 to 7 days. A prescription of hydrocodone/apap 7. 5/750 to be taken 1 tablet 4 times daily was provided for pain. I was released from the clinic with instructions to take the medication as prescribed, use advil / tylenol for moderate pain and the hydrocodone for extreme pain. I should return if i have any add'l problems. On (b)(6) 2011, both ears were very irritated and painful and the pain was not well managed with 800 mg ibuprofen. As such, the ear drops were used in both ears for 5 days per instructions. As i needed to be able to drive i used 800 mg of ibuprofen every 4 hours for pain and took the hydrocodone at night for sleep. The pain resolved after 4 days for the most part. The hearing in my ears is still somewhat affected.
Patient Sequence No: 1, Text Type: D, B5