MAUDE Adverse Event Report: COL OPTIC WHITE PROF KIT IN-OFFICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Inflammation (1932); Pain (1994); Skin Discoloration (2074); Swelling (2091); Ulceration (2116); Burning Sensation (2146); Discomfort (2330); Sensitivity of Teeth (2427)

Event Date 08/15/2019

Event Type  Injury  

Event Description

I had a fracture [tooth fracture].Large abscess on tooth 19 [tooth abscess].Periodontal ligament is so inflamed [ligamentitis].Very widened periodontal ligaments around teeth 18 and 19 [ligament disorder] grinding teeth [bruxism].Clenching my teeth [bruxism].It burned her gums [gingival discomfort].Ulcerated gums [gingival ulceration].Gums turned reddish purple [gingival discolouration].Ulcer in mouth [mouth ulceration].Lot of discomfort [discomfort].I had a lot of pain associated with the healing process [pain].Tooth pain on the ll side of my mouth [toothache].Severe pain in the ll side of my mouth [oral pain].Bottom lip was swollen [lip swelling].This is a spontaneous report received from a consumer who is also dental hygienist (adult female and age unknown) on (b)(6) 2019 who used col optic white prof kit in-office and experienced burning gums, ulcer mouth, bottom lip swelling, gums turned reddish purple and lot of discomfort.No known allergies were provided.On (b)(6) 2019, consumer had col optic white prof kit in-office applied for teeth whiten.She reported that barrier was placed properly and on the second round she felt intense burning of her gums.She reported she formed ulcers by the bottom molar area.She also had bottom lip swelling and her gums turned reddish purple.She applied topical vitamin e and used magic mouthwash as treatment.Consumer reporter the events were worse on (b)(6) 2019 than the prior day.She stated she may have experienced slight improvement on (b)(6), but still she had a lot of discomfort.On (b)(6) 2019 consumer stopped using col optic white prof kit in-office.Outcome of the events were not resolved at the time of this report.Additional information received from a consumer on (b)(6) 2019 and case was upgraded from non-serious to serious.Consumer reported that it took a week for her gums to feel better and she had lot of pain associated with the healing process.Consumer was prescribed miracle mouthwash and used otc products (unspecified) to help numb her mouth.She stated that she ate soft foods for the first five days and eventually could brush her teeth very gently with a post-surgical toothbrush, which she was still using at time of reporting.She stated that she was clenching and grinding her teeth severely due to the pain.On (b)(6), she started developing tooth pain on the lower left side of her mouth.She took aleve to help with the discomfort.By the morning (b)(6), she had severe pain on the lower left side of her mouth and had a hygienist in the dental office take an x-ray.The x-ray showed a large abscess on tooth 19 with very widened periodontal ligaments around teeth 18 and 19 due to grinding her teeth from being in such pain from her burned and ulcerated gums.In (b)(6) 2019, dentist numbed her mouth to relieve the pain and informed her that tooth 19 would need to be extracted with a bone graft and an implant after healing.Dentist was also concerned about tooth 18, because the periodontal ligament was so inflamed and she had a fracture.Consumer was prescribed amoxicillin to start immediately.Consumer reported she had to have her mouth numbed again 3 hours later and on the same day the dentist extracted tooth 18 and did a bone graft at around 05:00 pm.Consumer stated that she went home immediately and went to bed sleeping upright as instructed after extraction, however, when the anesthetic wore off she was in excruciating pain.Consumer contacted dentist and was advised to take ibuprofen and use ice packs and was also informed that root canal would be done on (b)(6) 2019.Consumer stated a medicated root canal was performed to relieve the severe pain and will be finished with a porcelain crown in 4-6 weeks.Consumer was prescribed a medrol dose pak.Consumer explained that she was recovering from the events of burning gum, ulcerated gums, gums turned reddish purple and the outcome of other events were unknown.

Event Description

I had a fracture [tooth fracture] large abscess on tooth 19 [tooth abscess] periodontal ligament is so inflamed [ligamentitis] very widened periodontal ligaments around teeth 18 and 19 [ligament disorder] grinding teeth [bruxism] clenching my teeth [bruxism] it burned her gums [gingival discomfort] ulcerated gums [gingival ulceration] gums turned reddish purple [gingival discolouration] ulcer in mouth [mouth ulceration] lot of discomfort [discomfort] i had a lot of pain associated with the healing process [pain] tooth pain on the ll side of my mouth [toothache] severe pain in the ll side of my mouth [oral pain] bottom lip was swollen [lip swelling] dental dam barrier came out in the mouth piece [device malfunction] could not go to work [loss of personal independence in daily activities] this is a spontaneous report received from a consumer who is also dental hygienist (adult female and age unknown) on (b)(6) 2019 who used col optic white prof kit in-office and experienced burning gums, ulcer mouth, bottom lip swelling, gums turned reddish purple and lot of discomfort.No known allergies were provided.On (b)(6) 2019, consumer had col optic white prof kit in-office applied for teeth whiten.She reported that barrier was placed properly and on the second round she felt intense burning of her gums.She reported she formed ulcers by the bottom molar area.She also had bottom lip swelling and her gums turned reddish purple.She applied topical vitamin e and used magic mouthwash as treatment.Consumer reporter the events were worse on (b)(6) 2019 than the prior day.She stated she may have experienced slight improvement on 09aug, but still she had a lot of discomfort.On (b)(6) 2019 consumer stopped using col optic white prof kit in-office.Outcome of the events were not resolved at the time of this report.Additional information received from a consumer on (b)(6) 2019 and case was upgraded from non-serious to serious.Consumer reported that it took a week for her gums to feel better and she had lot of pain associated with the healing process.Consumer was prescribed miracle mouthwash and used otc products (unspecified) to help numb her mouth.She stated that she ate soft foods for the first five days and eventually could brush her teeth very gently with a post-surgical toothbrush, which she was still using at time of reporting.She stated that she was clenching and grinding her teeth severely due to the pain.On 12aug, she started developing tooth pain on the lower left side of her mouth.She took aleve to help with the discomfort.By the morning 14aug, she had severe pain on the lower left side of her mouth and had a hygienist in the dental office take an x-ray.The x-ray showed a large abscess on tooth 19 with very widened periodontal ligaments around teeth 18 and 19 due to grinding her teeth from being in such pain from her burned and ulcerated gums.In (b)(6) 2019, dentist numbed her mouth to relieve the pain and informed her that tooth 19 would need to be extracted with a bone graft and an implant after healing.Dentist was also concerned about tooth 18, because the periodontal ligament was so inflamed and she had a fracture.Consumer was prescribed amoxicillin to start immediately.Consumer reported she had to have her mouth numbed again 3 hours later and on the same day the dentist extracted tooth 18 and did a bone graft at around 05:00 pm.Consumer stated that she went home immediately and went to bed sleeping upright as instructed after extraction, however, when the anesthetic wore off she was in excruciating pain.Consumer contacted dentist and was advised to take ibuprofen and use ice packs and was also informed that root canal would be done on (b)(6) 2019.Consumer stated a medicated root canal was performed to relieve the severe pain and will be finished with a porcelain crown in 4-6 weeks.Consumer was prescribed a medrol dose pak.Consumer explained that she was recovering from the events of burning gum, ulcerated gums, gums turned reddish purple and the outcome of other events were unknown.Additional information was received from the consumer on (b)(6) 2019.Consumer's age was provided as 48-years and weight as 119 pounds.Consumer's medical history included an existing root canal and pfm (porcelain- fused-to metal) crown of #19 tooth.Consumer reported that col optic white prof kit in-office whitening procedure was prepared and applied as per instruction included with product.Consumer reported tissue was properly covered.Consumer stated that during the second round of whitening she started feeling extreme burning and product (mouthpiece) was removed.When mouthpiece was removed, the dental dam barrier came out in the mouth piece.Consumer reported her gums were burned and ulcerated throughout her mouth.She reported all whitening solution was rinsed and removed from her mouth and she immediately took 600 mg ibuprofen, topic anesthetic was applied to her gums and vitamin e oil was applied to her gums.Consumer was prescribed miracle mouthwash which provided mild temporary relief.Consumer stated that she was unable to brush for first two days and then used a post-surgical toothbrush avoiding gums for next several days.After three+ weeks she was finally able to resume brushing with her sonic toothbrush.Consumer reported clenching her teeth due to painful gums and began experiencing intolerable pain on lower left side of mouth on (b)(6) 2019.Consumer's tooth #19 had a "big" buccal burn and was abscessed.She was prescribed amoxicillin and her mouth was numbed with lidocaine to tolerate the pain.On (b)(6) 2019, tooth #19 was extracted with a bone graft.The evening of (b)(6) 2019, after the anesthetic wore off, she was again in excruciating pain.On (b)(6) 2019, she could not go to work due to the events.Consumer reported she had a fracture in tooth #18, which required a root canal.Consumer stated that she was now healing from tooth #19 being extracted and will need an implant.Consumer's tooth #18 will need a build up and porcelain crown.At the time of this report, consumer was recovering from the events.

• Brand Name: COL OPTIC WHITE PROF KIT IN-OFFICE
• Type of Device: COL OPTIC WHITE PROF KIT IN-OFFICE
• MDR Report Key: 8952892
• MDR Text Key: 161075585
• Report Number: 2218158-2019-00002
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: K122725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 10/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 54