FDA Adverse Event
Other
Summary report: N
TOPICAL SKIN ADHESIVE
MDR report key: 508172
·
Received January 22, 2004
Report
- Report Number
- 1034548-2004-00001
- Event Type
- Other
- Date Received
- January 22, 2004
- Date of Event
- October 15, 2003
- Report Date
- January 22, 2004
- Manufacturer
- CLOSURE MEDICAL CORP.
- Product Code
- MPN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PRODUCT WAS USED TO CLOSE A FOREHEAD LACERATION ON PT OF UNK GENDER OR AGE. THE PHYSICIAN REQUESTED INSTRUCTIONS FOR REMOVAL SINCE IT WAS DETERMINED THAT THE WOUND APPEARED TO BE INFECTED. THE EVENT WAS CLASSIFIED AS AN INFECTION. THE INSTRUCTIONS WERE GIVEN PER PROTOCOL AND THE CONSEQUENCES TO THE PT ARE UNK. THE DISTRIBUTOR MADE FIVE ATTEMPTS TO CONTACT THE REPORTER WITHOUT SUCCESS. 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 | TOPICAL SKIN ADHESIVE | TISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION | MPN | CLOSURE MEDICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |