FDA Adverse Event
Injury
Summary report: N
CVS
MDR report key: 4257593
·
Received November 14, 2014
Report
- Report Number
- 1038758-2014-00037
- Event Type
- Injury
- Date Received
- November 14, 2014
- Report Date
- November 13, 2014
- Manufacturer
- EUROMED INC.
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
HYDROCOLLOIDS ARE DESIGNED TO STAY ON FOR UP TO 7 DAYS. UNDER ROUTINE USE, ALLOW THE PRODUCT TO LOOSEN NATURALLY. REMOVAL OF BANDAGE CAN BE FACILITATED BY CAREFULLY LIFTING EDGES OF THE DRESSING WITH OTHER HAND AND GENTLY ROLLING DRESSING OFF OF THE WOUND SITE.
Description of Event or Problem · 1
ON (B)(6) 2014: PULLED SKIN OFF WITH BANDAGE DURING REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736599 | CVS | HYDROCOLLOID BANDAGES | KGX | EUROMED INC. | UPC 50428044513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |