MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-16 for DENVER SPLINT, SERIES 1500 * 10-1500-05KS manufactured by Shippert Medical Technologies.
[503114]
Surgeon applied denver splint to patient's nose. While doing so, noted the tan (beige) paint was flaking off the splint. Because the surgeon had already adhered the splint and molded it to shape, he chose not to remove this one and replace it with another. There were no paint flakes observed in patient's eye area. Earlier this year, we reported the same problem with flaking paint from the denver splint. After the earlier occurrence the manufacturer was contacted and did indicate awareness of this problem. In response, manufacturer requested that we replace our stock with a new supply and this was done. After this occurrence, again manufacturer was contacted. Manufacturer again requested that we pull current stock and replace with a new supply.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 755828 |
| MDR Report Key | 755828 |
| Date Received | 2006-08-16 |
| Date of Report | 2006-08-15 |
| Date of Event | 2006-08-09 |
| Report Date | 2006-08-15 |
| Date Reported to FDA | 2006-08-16 |
| Date Added to Maude | 2006-08-31 |
| 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 | DENVER SPLINT, SERIES 1500 |
| Generic Name | SPLINT, NASAL |
| Product Code | EPP |
| Date Received | 2006-08-16 |
| Returned To Mfg | 2006-08-16 |
| Model Number | * |
| Catalog Number | 10-1500-05KS |
| Lot Number | 10030 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 743661 |
| Manufacturer | SHIPPERT MEDICAL TECHNOLOGIES |
| Manufacturer Address | 6248 SOUTH TROY CIRCLE, UNIT A CENTENNIAL CO 80111 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-16 |