FDA Adverse Event
Other
Summary report: N
3M LOBAN 2 ANTIMICROBIAL DRAPE
MDR report key: 1121407
·
Received August 13, 2008
Report
- Report Number
- 2110898-2008-00017
- Event Type
- Other
- Date Received
- August 13, 2008
- Date of Event
- December 2, 2005
- 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER APPROVED, DRUG FACTS, WARNINGS FOR DURAPREP SURGICAL SOLUTION NOW STATE "TO AVOID SKIN INJURY, CARE SHOULD BE TAKEN WHEN REMOVING DRAPES, TAPES ETC. APPLIED OVER [DURAPREP] FILM." 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 THE SKIN OF PEDIATRIC PATIENTS, PREPPED WITH 3M DURAPREP SURGICAL SOLUTION, IS PEELING OFF WITH THE DRAPES AND PRESUMES IT IS DUE TO THE COMBINATION OF THE NEW OR LIGHTS AND THE DRAPES GETTING HOT. REPORTEDLY TREATED WITH POLYSPORIN AND A DRESSING.
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 | Other | UNSPCIFIED OR LIGHT SOURCE| 3M DURAPREP SURGICAL SOLUTION |