MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-02 for CAPRI APPLICATOR manufactured by Varian Medical Systems.
[4456011]
Pt receiving treatment utilizing varian capri disposable single-use treatment device in radiation oncology. Device has a soft foam core and 13 lumens/channels for the hdr brachytherapy source to travel within. Device is inflatable. Channel 1, the most distal channel, was not in the same location as all other capri's used. It was later discovered to be approx 1. 0cm inferior of mfr specs. Pt was treated with this device and did not receive the prescribed dose to all parts of the tumor as would normally occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036471 |
| MDR Report Key | 3866581 |
| Date Received | 2014-06-02 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-21 |
| Date Added to Maude | 2014-06-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPRI APPLICATOR |
| Generic Name | CAPRI APPLICATOR |
| Product Code | JAQ |
| Date Received | 2014-06-02 |
| Lot Number | 1311-2043 |
| ID Number | CV00001000 |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-02 |