MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET manufactured by Nucletron B.v..
[139839459]
The manufacturer's investigation is on-going and further information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[139839460]
The customer reported that the vaginal tube for the 25, 30 and 25 mm set will not stay locked in place. Unfortunately a patient's vaginal cuff was perforated when the vaginal tube became dislodged.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9611894-2019-00001 |
MDR Report Key | 8377997 |
Date Received | 2019-02-28 |
Date of Report | 2019-05-13 |
Date of Event | 2019-01-31 |
Date Mfgr Received | 2019-02-01 |
Date Added to Maude | 2019-02-28 |
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 | 3 |
Event Location | 3 |
Manufacturer Contact | PMS |
Manufacturer Street | LINAC HOUSE FLEMING WAY |
Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
Manufacturer Country | UK |
Manufacturer Postal | RH10 9RR |
Manufacturer G1 | NUCLETRON B.V. |
Manufacturer Street | WAARDGELDER 1 |
Manufacturer City | VEENENDAAL 3905TH |
Manufacturer Country | NL |
Manufacturer Postal Code | 3905 TH |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET |
Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
Product Code | JAQ |
Date Received | 2019-02-28 |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NUCLETRON B.V. |
Manufacturer Address | WAARDGELDER 1 VEENENDAAL 3905TH NL 3905 TH |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-02-28 |