MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-03-03 for SOOTH-N-SEAL LIQUID PROTECTANT SNS manufactured by Closure Medical Corp..
[18147050]
User did not realize that product would form a "like a glue" over the sore in their mouth. User applied the adhesive and after about ten minutes it felt uncomfortable and user tried to remove the adhesive from their mouth using their teeth to pry the adhesive off and their tooth broke off. User did not really know, how the product works, that it would form a seal over the sore. User could not eat or drink with the adhesive in place. User last went to dentist maybe a year ago but insists there is nothing wrong with their teeth. Dentist states that the damage to the tooth is too close to the nerve to correct as he normally would, he had to do it another way. Dentist states that when the user pried the adhesive off his tooth. User fractured the distal occlusal surface to tooth # 19. The dentist reports that when he saw the user there was a fracture of the dol cusp with active decay present. The decay was removed, the fractured cusp alleviated, an indirect cap was placed due to the close proximity to the nerve, and a composite restoration was choosen to help hold the tooth together.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034548-2005-00006 |
| MDR Report Key | 579355 |
| Report Source | 08 |
| Date Received | 2005-03-03 |
| Date of Report | 2005-03-03 |
| Date of Event | 2004-11-12 |
| Date Mfgr Received | 2005-02-10 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2005-03-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARK SPAIN |
| Manufacturer Street | 5250 GREENS DIARY RD |
| Manufacturer City | RALEIGH NC 27609 |
| Manufacturer Country | US |
| Manufacturer Postal | 27609 |
| Manufacturer Phone | 9197867800 |
| Manufacturer G1 | CLOSURE MEDICAL CORPORATION |
| Manufacturer Street | 5250 GREENS DIARY RD |
| Manufacturer City | RALEIGH NC 27609 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27609 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOOTH-N-SEAL LIQUID PROTECTANT |
| Generic Name | LIQUID PROTECTANT FOR CANKER SORE PAIN RELIEF |
| Product Code | MZW |
| Date Received | 2005-03-03 |
| Returned To Mfg | 2005-01-10 |
| Model Number | NA |
| Catalog Number | SNS |
| Lot Number | 054130 |
| ID Number | NA |
| Device Expiration Date | 2006-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 569203 |
| Manufacturer | CLOSURE MEDICAL CORP. |
| Manufacturer Address | 5250 GREENS DAIRY RD. RALEIGH NC 27616 US |
| Baseline Brand Name | SOOTH-N-SEAL LIQUID PROTECTANT |
| Baseline Generic Name | LIQUID PROTECTANT FOR CANKER SORE PAIN RELIEF |
| Baseline Model No | NA |
| Baseline Catalog No | SNS |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-03 |