FDA Adverse Event
Injury
Summary report: N
DERMABOND ADVANCED
MDR report key: 2821867
·
Received November 6, 2012
Report
- Report Number
- 2210968-2012-07063
- Event Type
- Injury
- Date Received
- November 6, 2012
- Date of Event
- September 27, 2012
- Report Date
- October 10, 2012
- Manufacturer
- ETHICON, INC.
- Product Code
- MPN
- PMA / PMN Number
- P960052
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
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 UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL ADHESIVE WAS USED. THE PATIENT DEVELOPED AN ALLERGIC REACTION AT THE SITE OF APPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMABOND ADVANCED | TOPICAL SKIN ADHESIVE | MPN | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |