FDA Adverse Event
Other
Summary report: N
3M LOBAN 2 ANTIMICROBIAL DRAPE
MDR report key: 1121403
·
Received August 13, 2008
Report
- Report Number
- 2110898-2008-00015
- Event Type
- Other
- Date Received
- August 13, 2008
- Date of Event
- June 14, 2007
- Report Date
- July 28, 2008
- Manufacturer
- 3M HEALTH CARE
- Product Code
- KKX
- PMA / PMN Number
- K801550
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT IS BEING REPORTED FOLLOWING A REVIEW OF PREVIOUS CUSTOMER REPORTS OF SKIN STRIPPING. THIS EVENT WAS NOT INITIALLY REPORTED DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE USER. THE INFORMATION REMAINS LIMITED, HOWEVER, A CONSERVATIVE APPROACH IS BEING TAKEN AND A REPORT FILED.
Description of Event or Problem · 1
CUSTOMER REPORTED SKIN OF A PEDIATRIC PATIENT (LESS THAN 1 YEAR OLD) WAS RED UNDER ADHESIVE OF BOTH LOBAN AND KC DRAPES. THE PATIENT UNDERWENT A MIDSTERNUM INCISION FOR A CARDIAC, OPEN HEART, PROCEDURE. THE PATIENT WAS DIAGNOSED AS 2ND DEGREE ADHESIVE BURN, AND TREATED WITH SILVADENE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3M LOBAN 2 ANTIMICROBIAL DRAPE | ANTIMICROBIAL SURGICAL DRAPE | KKX | 3M HEALTH CARE | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |