FDA Adverse Event
Other
Summary report: N
DERMABOND TOPICAL SKIN ADHESIVE PROPEN DOMESTIC
MDR report key: 546960
·
Received October 1, 2004
Report
- Report Number
- 1034548-2004-00015
- Event Type
- Other
- Date Received
- October 1, 2004
- Report Date
- September 28, 2004
- Manufacturer
- CLOSURE MEDICAL CORP.
- Product Code
- MPN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE COMPLAINT WAS OPENED AT ETHICON, INC IN 2004, THE EVENT OCCURRED WITHIN TWO WEEKS PRIOR TO THAT DATE. THE REPORT STATES THE PRODUCT WAS USED TO CLOSE A LACERATION ON THE NOSE OF A PT. THE WOUND WAS THOROUGHLY CLEANED BY THE ATTENDING DOCTOR AND THE WOUND WAS WELL APPROXIMATED. THERE HAVE BEEN SEVERAL ATTEMPTS TO GAIN MORE INFO ON THIS EVENT, BUT AT THIS TIME NO MORE INFO HAS BEEN PROVIDED. PRODUCT WAS NOT RETURNED. THE CURRENT CONDITION OF THE PT IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMABOND TOPICAL SKIN ADHESIVE PROPEN DOMESTIC | TISSUE ADHESIVE FOR SOFT TISSUE APPROX | MPN | CLOSURE MEDICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |