N
Patient 1
INVESTIGATION IS STILL ONGOING. WILL PROVIDE FOLLOW UP WHEN MORE INFORMATION IS RECEIVED.
MAUDE MDR 6898761
- MDR report key
- 6898761
- Report number
- 1060680-2017-00017
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-08-24
- Date received
- 2017-09-27
- 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
- MS. SARAH BENNETT
- Address
- 200 DEBUSK LANE POWELL TN 37849 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SAFETYSCALPEL ASMB #3 FITMENT, #11 BLADE, BLUE NS | HANDLE, SCALPEL | S & S SURGICAL | GDZ | SM4511NS | 012072 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-09-27 | 0 | 1. R |
Event Narratives#
D
Patient 1
>> QUALITY ISSUE INFORMATION