FDA Adverse Event
Injury
Summary report: N
DUODERM EXTRA THIN STERILE DRESSING
MDR report key: 889216
·
Received August 2, 2007
Report
- Report Number
- 2243969-2007-00016
- Event Type
- Injury
- Date Received
- August 2, 2007
- Date of Event
- July 5, 2007
- Report Date
- July 5, 2007
- Manufacturer
- CONVATEC
- Product Code
- FRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REPORTED TO THE FDA ON AUGUST 2, 2007.
Description of Event or Problem · 1
DIABETIC PATIENT REPORTED TO HAVE AN INFECTED SURGICAL WOUND IN AN UNKNOWN ANATOMICAL AREA WHILE USING VARIHESIVE EXTRA DUNN (DUODERM EXTRA THIN CGF DRESSING). IT IS NOW KNOWN WHETHER THE INFECTION PRE-EXISTED THE USE OF THIS DRESSING OR THE LENGTH OF TIME BETWEEN THE APPEARANCE OF CLINICAL SIGNS OF INFECTION AND WHEN MEDICAL ATTENTION WAS SOUGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUODERM EXTRA THIN STERILE DRESSING | WOUND DRESSING | FRO | CONVATEC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |