FDA Adverse Event
Injury
Summary report: N
SPONGOSTAN
MDR report key: 7643306
·
Received June 27, 2018
Report
- Report Number
- 3008478369-2018-00005
- Event Type
- Injury
- Date Received
- June 27, 2018
- Product Code
- LMF
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PRODUCT COMPLAINT # ==> PC-(B)(4). DATE SENT TO THE FDA: 09/23/2020. CORRECTED INFORMATION: B1, B2, H1 ¿ THIS MEDWATCH IS NOT REPORTABLE BY ETHICON, INC. AS THE IMPORTER BECAUSE THIS DEVICE WAS NOT IMPORTED INTO THE USA. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANKLE RECONSTRUCTION PROCEDURE AND AN ABSORBABLE HEMOSTATIC SPONGE WAS USED. THE WAS OPERATED ON THREE TIMES. DATE OF EVENT WAS 2012. OUTCOME OF EVENT, PROLONGATION OF HOSPITAL STAY. NO MORE DETAILS ARE PROVIDED AT THE MOMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 482863 | SPONGOSTAN | ABSORBABLE HEMOSTATIC | LMF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |