MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-08 for 3M CLINPRO SEALANT UNK 12627 manufactured by 3m Espe Dental Products.
[21395665]
Device 2. 3m espe was recently notified of an event that occurred approximately 1-1/2 years ago. On the day of the event, a pediatric patient visited the reporting dentist for a treatment that involved two 3m espe products, filtek (tm) p60 posterior restorative and clinpro (tm) sealant. The patient left the office and later the same day was seen by a pediatric dentist or pediatric physician (details on the type of professional are not available to 3m espe). It is reported that following a shot of some type (details on type of shot are not available to 3m espe), the patient stopped breathing and went into a coma, where he has remained for the last 1-1/2 years. Additional details on this situation are not available to 3m espe; because of potential and pending litigation, the dentist making the report to 3m espe was not willing to provide any additional information for use in the investigation of the event.
Patient Sequence No: 1, Text Type: D, B5
[21472007]
Device not returned; therefore, no evaluation was conducted. Both 3m espe products reported to have bene used in treatment of this patient have very favorable clinical use histories without any other allegation of this type. Based on the biocompatibility assessments of these products along with their favorable use history, this type of adverse health effect is not expected from the intended use of the products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2007-00008 |
| MDR Report Key | 892665 |
| Report Source | 05 |
| Date Received | 2007-08-08 |
| Date of Report | 2007-08-07 |
| Date of Event | 2006-02-16 |
| Date Mfgr Received | 2006-07-23 |
| Date Added to Maude | 2007-08-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CAROLYN KRAMPE |
| Manufacturer Street | 3M CENTER, BLDG. 260-2A-17 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517361148 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS DIVISION |
| Manufacturer Street | 2111 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M CLINPRO SEALANT |
| Generic Name | PIT AND FISSURE SEALANT |
| Product Code | EBC |
| Date Received | 2007-08-08 |
| Model Number | UNK |
| Catalog Number | 12627 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 873898 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2111 MCGAW AVENUE IRVINE CA 92614 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-08 |