FDA Adverse Event
Other
Summary report: N
CURASORB CAL ALGNT DSG 2X2 STRL
MDR report key: 3766777
·
Received April 9, 2014
Report
- Report Number
- 1018120-2014-00007
- Event Type
- Other
- Date Received
- April 9, 2014
- Report Date
- March 25, 2014
- Manufacturer
- COVIDIEN
- Product Code
- FRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A STERILE DRESSING. THE CUSTOMER REPORTS THE PT (FEMALE) HAD CRUSTS IN THE DRESSING AND THEY HAD TO OPERATE TO REMOVE THE CRUSTS. THE TIME OF THE SURGERY EXTENDED MORE THAN 30 MINUTES. TISSUE LOSS/DAMAGES: YES, BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO REINFORCING MATERIAL USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215609 | CURASORB CAL ALGNT DSG 2X2 STRL | STERILE DRESSING | FRO | COVIDIEN | 9232 | 130001713362X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |