FDA Adverse Event
Other
Summary report: N
DERMABOND TOPICAL SKIN ADHESIVE
MDR report key: 493342
·
Received October 31, 2003
Report
- Report Number
- 1034548-2003-00024
- Event Type
- Other
- Date Received
- October 31, 2003
- Date of Event
- September 29, 2003
- Report Date
- October 31, 2003
- Manufacturer
- CLOSURE MEDICAL CORP.
- Product Code
- MPN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FROM THE DISTRIBUTOR'S REPORT: PRODUCT WAS APPLIED TO A FACIAL LACERATION ON A PT. THE PRODUCT GOT INTO THE PT'S EYE AND THE EYE WAS "SEALED SHUT". THE CALLER WAS ADVISED TO RINSE THE EYE WITH SALINE, USE A PETROLEUM BASED OINTMENT, PATCH THE EYE, AND HAVE THE PT SEEN BY AN OPHTHALMOLOGIST. A MESSAGE WAS LEFT FOR THE ATTENDING TO RETURN CALL AND PROVIDE ADDITIONAL SPECIFICS. AT THIS TIME NO ADDITIONAL INFO HAS BEEN PROVIDED. PRODUCT WAS NOT RETURNED.
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 | UNKNOWN | Other |