FDA Adverse Event
Injury
Summary report: N
3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE
MDR report key: 2083354
·
Received April 20, 2011
Report
- Report Number
- 2110898-2011-00046
- Event Type
- Injury
- Date Received
- April 20, 2011
- Date of Event
- January 26, 2011
- Report Date
- March 7, 2011
- Manufacturer
- 3M HEALTH CARE
- Product Code
- KKX
- PMA / PMN Number
- K801550
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE PT EFFECTS WERE REPORTED. IF ADD'L INFO IS REC'D, A F/U REPORT WILL BE SUBMITTED. NO EVAL WILL BE PERFORMED.
Description of Event or Problem · 1
3M REC'D INFO FROM A CUSTOMER REPORTING ON A MEDWATCH FORM ((B)(4)) THAT A (B)(6) FEMALE SUSTAINED A 4 X 8 CM SKIN TEAR TO THE NECK UPON REMOVAL OF THE 3M IOBAN SURGICAL DRAPE. REPORTEDLY, THE PT WAS TREATED WITH XEROFORM AND THE INJURY HAS HEALED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE | 878.4370 DRAPE, SURGICAL | KKX | 3M HEALTH CARE | NA | NK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Required Intervention | NK |