FDA Adverse Event
Other
Summary report: N
DERMABOND TOPICAL SKIN ADHESIVE
MDR report key: 383219
·
Received March 11, 2002
Report
- Report Number
- 1034548-2002-00018
- Event Type
- Other
- Date Received
- March 11, 2002
- Date of Event
- December 28, 2001
- Report Date
- March 11, 2002
- Manufacturer
- CLOSURE MEDICAL CORP.
- Product Code
- MPN
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FROM INFO SUPPLIED BY DISTRIBUTOR FROM MEDWATCH FORM 3500. DERMABOND TOPICAL SKIN ADHESIVE WAS USED TO CLOSE A LACERATION BELOW THE PT'S EYE AT ER. THE PT'S EYE WAS "DERMABONDED CLOSED" AFTER WHICH, A SOLUTION OF LACROLUBE AND SALINE WERE ADMINISTERED FOR 45 MINUTES AND THE EYE WAS OPENED. THE LOWER EYELASHES WERE REMOVED AND THE EYE WAS RED AND SWOLLEN. DISTRIBUTOR FAXED A LETTER TO CONTACT REQUESTING MORE INFO ON EVENT. HOSPITAL SENT LETTER TO DISTRIBUTOR STATING THAT "AFTER AN INTERNAL INVESTIGATION, THEY DETERMINED THE EVENT WAS NOT A RESULT OF PRODUCT FAILURE, THEREFORE THEY SEE NO NEED TO PROVIDE THE ADD'L INFO REQUESTED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMABOND TOPICAL SKIN ADHESIVE | TISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION | MPN | CLOSURE MEDICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |