FDA Adverse Event
Other
Summary report: N
DUODERM CGF EXTRA THIN
MDR report key: 597479
·
Received April 30, 2005
Report
- Report Number
- 1049092-2005-00019
- Event Type
- Other
- Date Received
- April 30, 2005
- Date of Event
- June 14, 1998
- Report Date
- April 29, 2005
- Manufacturer
- CONVATEC
- Product Code
- NAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RNET REPORTED PORTENTIAL ALLERIGIC REACTION TO PATIENT USING DUODERM CGR EXTRA DRESSING. CUSTOMER WENT TO ER ON WITH "MASSIVE BLISTERING AND SEVERE ITCHING" DIRECTLY UNDER DUODERM DRESSING.DUODERM DRESSING WAS DISCONTINUED. CUSTOMER WAS TREATMENT. DUODERM DRESSING WAS DISCONTINUED. CUSTOMER WAS TREATED WITH IV BENEDRYL AND TOPICAL STEROID CREAM WAS APPLIED TO THE AFFECTED AREA. CUSTOMER DID NOT REQUIRE ADMISSION TO THE HOSPITAL. A FOLLOW UP CALL WAS MADE 1 MONTH LATER TO THE RNET. RNET REPORTS THE SKIN RASH HAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUODERM CGF EXTRA THIN | WOUND DRESSING | NAD | CONVATEC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other | NONE REPORTED |