N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9664823
- MDR report key
- 9664823
- Report number
- 1717344-2020-00114
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-22
- Date received
- 2020-02-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA HERNANDEZ
- Address
- 5920 LONGBOW DRIVE BOULDER CO 80301 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HYSTEROSCOPE | HYSTEROSCOPE (AND ACCESSORIES) | COVIDIEN MFG DC BOULDER | HIH | 72205001 | 72205001 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-04 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT READINGS WERE WAY OFF RIGHT OUT OF THE BOX. THERE WAS NO PATIENT INVOLVEMENT.
N
Patient 1
THIS EVENT HAS BEEN REASSESSED AND FOUND NOT TO BE A REPORTABLE EVENT AND IS NOT ASSOCIATED WITH A SERIOUS INJURY OR POTENTIAL FOR SERIOUS INJURY WITH REOCCURRENCE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.