FDA Adverse Event
Malfunction
Summary report: N
CURASALT DSG KERLIX S/S 6X6.75
MDR report key: 1122164
·
Received August 14, 2008
Report
- Report Number
- 1018120-2008-00016
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- May 28, 2008
- Report Date
- August 11, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- NAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- 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 TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH KERLIX GAUZE. THE CUSTOMER COMPLAINED THEY EXPERIENCED THREADS UPON REMOVAL OF THE DRESSING FROM THE WOUND SITE. AFTER REMOVING THE CURASALT, THE RN REMOVED THE THREADS WITH STERILE TWEEZERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURASALT DSG KERLIX S/S 6X6.75 | KERLIX GAUZE | NAB | TYCO HEALTHCARE/KENDALL | 3339 | 7270501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |