FDA Adverse Event
Other
Summary report: N
ACTISORB ACTIVATED CHARCOAL CLOTH DRESSING
MDR report key: 2640333
·
Received June 27, 2012
Report
- Report Number
- 3007663067-2012-00003
- Event Type
- Other
- Date Received
- June 27, 2012
- Date of Event
- November 1, 2011
- Report Date
- June 26, 2012
- Manufacturer
- SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
- Product Code
- FRO
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION - REACTION, LOCAL. DRESSINGS WERE KEPT IN PLACE WITH PROFORE. FOLLOWING REMOVAL OF THE DRESSINGS AND INTRODUCTION OF A CORTICOIDE SYMPTOMATIC TREATMENT, THE PATIENT HAS SINCE FULLY RECOVERED.
Description of Event or Problem · 1
FEMALE, (B)(6), PAST HISTORY OBESITY, ARTERIAL HYPERTENSION AND CHRONIC VENOUS ULCERS. THE (B)(6) 2011, INITIATION OF LOCAL TREATMENT WITH ACTIVATED CHARCOAL CLOTH DRESSING FOR CHRONIC ULCER WITH RECENT DEGRADATION. THE (B)(6) 2011, GENERALIZED ITCHY RASH, IN A AEG CONTEXT (ALTERATION OF THE GENERAL STATE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTISORB ACTIVATED CHARCOAL CLOTH DRESSING | ODOUR - ABSORBENT DRESSING ANTIMICROBIAL | FRO | SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |