N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9786612
- MDR report key
- 9786612
- Report number
- 1717344-2020-00241
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-05
- Date received
- 2020-03-04
- 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 | SITUATE | COUNTER, SPONGE, SURGICAL | COVIDIEN MFG DC BOULDER | LWH | 01-0043 | 01-0043 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-04 | 0 | 1. O |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT WAS SCANNED TWICE WITH THE MAT AND TWICE SHOWED DETECTION. THE COUNT WAS CORRECT BUT AN X-RAY WAS BROUGHT IN AND IMAGES WERE RETRIEVED. ANALYSIS OF THE X-RAY IMAGE SHOWED NO RETAINED SPONGE. AFTER, FOUR MORE SCANS ON THE DEVICE WERE RAN AND ALL OF THEM WERE CLEAR. THE WAND WAS NEVER USED.