N
Patient 1
ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
MAUDE MDR 8633091
- MDR report key
- 8633091
- Report number
- 1226348-2019-00159
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-05-09
- Date received
- 2019-05-22
- 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
- USER KIMBERLY SHELLY
- Address
- 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-22 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WERE ONLY 9 OF THE 1/2" X 6" COTTONOIDS IN THE PACK AND IT SHOULD BE 10.