MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-01-05 for GLENROE ULTRA NON-LATEX ELASTICS UNK manufactured by Dentsply Glenroe.
[595678]
It was reported that a pt possibly had an allergic reaction after use of glenroe ultra non-latex elastics. Outcome of the event is not known as of this report.
Patient Sequence No: 1, Text Type: D, B5
[7941061]
Further info pertaining to this event will be reported if it becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036212-2006-00601 |
| MDR Report Key | 802838 |
| Report Source | 08 |
| Date Received | 2007-01-05 |
| Date of Report | 2006-12-06 |
| Date of Event | 2006-12-06 |
| Date Mfgr Received | 2006-12-06 |
| Date Added to Maude | 2007-01-12 |
| 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 | DR PATRICIA KIHN |
| Manufacturer Street | SUEQUEHANNA COMMERCE CENTER W 221 W PHILA ST, STE 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY GLENROE |
| Manufacturer Street | 1912 44TH AVE, EAST |
| Manufacturer City | BRADENTON FL 34203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLENROE ULTRA NON-LATEX ELASTICS |
| Generic Name | ECI |
| Product Code | ECI |
| Date Received | 2007-01-05 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 790342 |
| Manufacturer | DENTSPLY GLENROE |
| Manufacturer Address | * BRADENTON FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-01-05 |