FDA Adverse Event
Other
Summary report: N
DERMABOND TOPICAL SKIN ADHESIVE
MDR report key: 498230
·
Received November 25, 2003
Report
- Report Number
- 1034548-2003-00025
- Event Type
- Other
- Date Received
- November 25, 2003
- Date of Event
- October 15, 2003
- Report Date
- November 25, 2003
- Manufacturer
- CLOSURE MEDICAL CORP.
- Product Code
- MPN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
PRODUCT WAS APPLIED TO A FOREHEAD LACERATION ON A PT. THE PRODUCT GOT INTO THE CHILD'S RIGHT EYE AND THE EYE WAS BONDED SHUT. A MESSAGE WAS LEFT FOR THE INITIAL REPORTER TO RETURN CALL AND PROVIDE ADD'L SPECIFICS. AT THIS TIME NO ADD'L 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 | 5 YR | Other |