MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-29 for THE DENVER SPLINT SERIES 1500 KIT SMALL/MEDIUM 10-1500-05K manufactured by Shippert Medical Technologies Corporation.
[21400261]
Surgeon applied denver splint after nasal surgery. It was noted that small amounts of the paint flaked off from the splint onto the patient's eye area. Surgeon immediately removed all of the flakes using a suction and there was no injury to the patient and the surgeon did not want the splint removed. On 3/23/06, a surgery staff member notified manufacturer and manufacturer indicated awareness of flaking problem, however they believed it was resolved. Manufacturer will replace our current stock of small/medium splints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 698120 |
| MDR Report Key | 698120 |
| Date Received | 2006-03-29 |
| Date of Report | 2006-03-29 |
| Date of Event | 2006-03-15 |
| Report Date | 2006-03-29 |
| Date Reported to FDA | 2006-03-29 |
| Date Added to Maude | 2006-04-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE DENVER SPLINT |
| Generic Name | SPLINT, NASAL |
| Product Code | EPP |
| Date Received | 2006-03-29 |
| Model Number | SERIES 1500 KIT SMALL/MEDIUM |
| Catalog Number | 10-1500-05K |
| Lot Number | 10030 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 687209 |
| Manufacturer | SHIPPERT MEDICAL TECHNOLOGIES CORPORATION |
| Manufacturer Address | 6248 SOUTH TROY CIRCLE, UNIT A CENTENNIAL CO 80111 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-29 |