MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-12-14 for NANODOT manufactured by Landauer Inc.
[2632504]
A customer in (b)(6) purchased the ldr nanodot and microstar dosimetry system to make in vivo dose measurements. The customer reported that their hosp requires the fda registration and ce info for the nanodot/microstar dosimetry system as part of their quality assurance program. In response, our subsidiary in (b)(4) contacted the customer to provide our fda registration number, and ce info (b)(4). The customer also reported that they are using the nanodot within a pt body cavity. We do not label or recommend the use of the nanodot within a pt body cavity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008426232-2011-00001 |
| MDR Report Key | 2498552 |
| Report Source | 01,05,06 |
| Date Received | 2011-12-14 |
| Date of Report | 2011-12-20 |
| Date Added to Maude | 2012-07-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2 SCIENCE RD |
| Manufacturer City | GLENWOOD IL 60425 |
| Manufacturer Country | US |
| Manufacturer Postal | 60425 |
| Manufacturer Phone | 7084418360 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NANODOT |
| Generic Name | OSL DOSIMETER |
| Product Code | LHO |
| Date Received | 2011-12-14 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LANDAUER INC |
| Manufacturer Address | GLENWOOD IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-14 |