FDA Adverse Event
Other
Summary report: N
ADAPTIC NON-ADHERING DRESSING
MDR report key: 2602463
·
Received May 31, 2012
Report
- Report Number
- 3007663067-2012-00002
- Event Type
- Other
- Date Received
- May 31, 2012
- Report Date
- May 31, 2012
- Manufacturer
- SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
- Product Code
- FRO
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION CODE: INCREASED SENSITIVITY.
Description of Event or Problem · 1
PT DEVELOPED A CHRONIC DISTURBANCE IN WOUND HEALING AFTER HE HAD AN ACCIDENT IN HIS PROFESSION (WORKING ACCIDENT). AFTER USE OF SEVERAL DIFFERENT PRIMARY DRESSINGS INCLUDING KNITTED CELLULOSE ACETATE NON-ADHERENT DRESSING, THERE APPEARED A CONTACT ECZEMA WITH SPREADING EFFECT. A PATCH TEST SHOWED A POSITIVE REACTION TO THE KNITTED CELLULOSE ACETATE NON-ADHERENT DRESSING. SUMYCIN CELESTAN V CREME WAS PRESCRIBED AND WOULD IS HEALING WITHOUT CONTACT ECZEMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTIC NON-ADHERING DRESSING | SURGICAL WOUND, NON-ADHERING DRESSING | FRO | SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |