FDA Adverse Event
Injury
Summary report: N
SURGIFOAM SPONGE SIZE 12-7 PRODUCT CODE 1972
MDR report key: 9784625
·
Received March 4, 2020
Report
- Report Number
- 3008478369-2020-00005
- Event Type
- Injury
- Date Received
- March 4, 2020
- Report Date
- March 4, 2020
- Manufacturer
- FERROSAN MEDICAL DEVICES A/S
- Product Code
- LMF
- UDI-DI
- 25712123000155
- PMA / PMN Number
- P990004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT COVERS PATIENT NO. 4 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN (B)(4)) FOR EVALUATION OF THIS EVENT. IT WAS REPORTED THAT SIMILAR EVENTS HAVE OCCURRED FOR AROUND 20 PATIENTS OVER A YEAR SPAN. THEREFORE, 20 INTERNAL REPORTS HAVE BEEN DONE AND ACCORDINGLY 20 REPORTS TO FDA ARE DONE. REFERENCE NUMBERS: FDA FERROSAN MEDICAL DEVICES A/S (B)(4).
Description of Event or Problem · 1
THIS REPORT COVERS PATIENT NO. 4 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN (B)(4)) FOR EVALUATION OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252705 | SURGIFOAM SPONGE SIZE 12-7 PRODUCT CODE 1972 | SURGIFOAM® SPONGE | LMF | FERROSAN MEDICAL DEVICES A/S | 25712123000155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |