N
Patient 1
SUBMIT DATE: 05/17/2017. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
MAUDE MDR 6572692
- MDR report key
- 6572692
- Report number
- 3009211636-2017-05110
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-20
- Date received
- 2017-05-17
- 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 | 2017-05-17 | 0 | 1. O |
Event Narratives#
D
Patient 1
THE CUSTOMER STATES THAT A PATIENT FROM THE AMBULATORY WARD SLID/FELL WHILE WALKING WITH TED STOCKINGS AND NO SHOES. SHE FELL ON HER BOTTOM AND KNOCKED HER HEAD ON THE BED. SHE HAD NO BRUISES BUT COMPLAINED OF SHOULDER PAIN. SHE WAS HOSPITALIZED AND IMAGERY SHOWED A FRACTURE AND A VERTEBRAL COMPRESSION. SHE THEN HAD A KYPHOPLASTY SURGERY DUE TO THE FRACTURE AND VERTEBRAL COMPRESSION. THE PATIENT HAD NO PREVIOUS HISTORY AND CAME THE SAME DAY RESECTION OF AN AXILLARY NODULE. THE CUSTOMER FURTHER REPORTS THAT THE SURGERY WENT WELL. THE SURGERY FOLLOWING THE EVENT ADDED 5 DAYS OF HOSPITALIZATION.
N
Patient 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
N
Patient 1
NO SAMPLE OR PICTURE WAS PROVIDED BY THE CUSTOMER FOR EVALUATION. ADDITIONALLY, DEVICE HISTORY RECORD COULD NOT BE REVIEWED SINCE THERE WAS NO LOT NUMBER PROVIDED. POTENTIAL ROOT CAUSES COULD BE RELATED TO IMPROPER USE OF PRODUCT BY THE CUSTOMER AND MATERIAL USED TO MANUFACTURE THE PRODUCT. THIS DEFECT HAS NOT BEEN CONFIRMED, SINCE THERE IS NO ENOUGH EVIDENCE PROVIDED BY THE CUSTOMER SUCH AS SAMPLE, LOT NUMBER, ITEM CODE OR PICTURE. AS PER THE MANUFACTURING PROCESS, ALL CONTROLS RELATED TO THE ACCEPTANCE OF THE PRODUCT ARE IN PLACE AND PERSONNEL IS APPROPRIATELY TRAINED IN ORDER TO PREVENT GETTING NONCONFORMING PRODUCT FROM THE MANUFACTURING PROCESS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.