N
Patient 1
SUBMIT DATE: 7/31/17. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
MAUDE MDR 6753904
- MDR report key
- 6753904
- Report number
- 9612030-2017-05130
- Event key
- 0
- Event type
- 3
- Date received
- 2017-07-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- EDWARD ALMEIDA
- Address
- 15 HAMPSHIRE STREET MANSFIELD MA 02048 US
- Phone
- 508-508-5084
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-07-31 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER STATES THAT THESE MARKERS WERE FOUND TO BE LEAKING.
N
Patient 1
THERE WERE NO SAMPLES SUBMITTED WITH THIS COMPLAINT. THE COMPLAINT SHALL BE REOPENED IF A SAMPLE IS RECEIVED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE DEFECT DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. SINCE A SAMPLE WAS NOT EVALUATED A ROOT CAUSE COULD NOT BE IDENTIFIED AND NO CORRECTIVE ACTIONS WERE DEEMED NECESSARY AT THIS MOMENT. THE CURRENT PROCESS IS RUNNING ACCORDING TO PRODUCT SPECIFICATIONS MEETING QUALITY ACCEPTANCE CRITERIA. A PRODUCTION NOTIFICATION WAS ISSUED TO ALL PERSONNEL TO ENSURE THAT THEY ARE AWARE ON THE CONDITION REPORTED BY THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.