MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-10-12 for SILTRAX EPI 00 07197 manufactured by Pascal Co., Inc..
[21986219]
This is a preliminary report awaiting more info from the dentist. It involves similar reactions to 3 patients over the course of 12 months. The dentist contacted our office requesting info on our medical device, siltrax epi 00, a gingival retraction cord containing epinephrine. The? 00? Indicates the size of the cord. During a procedure, where the dentist was administering several products, including siltrax epi, the pts experienced tissue and bone? Sloughing? (a term used the dentist). He was not clear as to the extent of the reaction. Because the dentist was using a variety of products from a variety of manufacturers, he was unsure which one or ones caused this reaction. He was calling the mfrs of all the products hoping to get some insights. The dentist said he took pictures and will forward them when available. Some of the pts received medical attention days after the dental procedure. The common therapy was administration of antibiotics. The dentist did not say whether this was successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011632-2012-00003 |
| MDR Report Key | 2796816 |
| Report Source | 07 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-11 |
| Date Mfgr Received | 2012-09-13 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2012-10-22 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT TENTARELLI, MGR |
| Manufacturer Street | 2929 N.E. NORTHUP WAY |
| Manufacturer City | BELLEVUE WA 98004 |
| Manufacturer Country | US |
| Manufacturer Postal | 98004 |
| Manufacturer Phone | 4256023633 |
| Manufacturer G1 | PASCAL CO., INC. |
| Manufacturer Street | 2929 N.E. NORTHUP WAY |
| Manufacturer City | BELLEVUE WA 98004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILTRAX EPI 00 |
| Generic Name | GINGIVAL RETRACTION CORD W/ EPINEPHRINE |
| Product Code | EIF |
| Date Received | 2012-10-12 |
| Returned To Mfg | 2012-09-27 |
| Model Number | NA |
| Catalog Number | 07197 |
| Lot Number | 090113 |
| ID Number | NA |
| Device Expiration Date | 2013-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PASCAL CO., INC. |
| Manufacturer Address | BELLEVUE WA 98004 US 98004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-12 |