FDA Adverse Event
Injury
Summary report: N
DERMABOND TOPICAL SKIN ADHESIVE
MDR report key: 2082278
·
Received May 9, 2011
Report
- Report Number
- 2210968-2011-00594
- Event Type
- Injury
- Date Received
- May 9, 2011
- Date of Event
- April 12, 2011
- Report Date
- April 14, 2011
- Manufacturer
- ETHICON
- Product Code
- MPN
- PMA / PMN Number
- P960052
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE TOPICAL SKIN ADHESIVE WAS APPLIED ON (B)(4) 2011. THE PATIENT EXPERIENCED SEVERE ITCHING AND BURNING ON (B)(4) 2011. THE BENEDRYL CREAM WAS APPLIED AND THE THE TOPICAL SKIN ADHESIVE WAS REMOVED BY GENTLE CLEANSING. THE PATIENT IS CURRENTLY FULLY RECOVERED.
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD A TOPICAL SKIN ADHESIVE APPLIED FOR AN UNKNOWN REASON. THE PATIENT EXPERIENCED A REACTION AND WAS INSTRUCTED TO USE BENEDRYL CREAM BY THE PHYSICIAN. THE CONDITION RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMABOND TOPICAL SKIN ADHESIVE | ADHESIVE, TOPICAL SKIN | MPN | ETHICON | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |