FDA Adverse Event
Malfunction
Summary report: N
DERMABOND ADVANCED TOPICAL SKIN ADHESIVE
MDR report key: 3233930
·
Received July 18, 2013
Report
- Report Number
- 2210968-2013-13689
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 24, 2013
- Report Date
- July 15, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- MPN
- PMA / PMN Number
- K100423
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2013 AND TOPICAL ADHESIVE WAS USED. THE PATIENT DEVELOPED SKIN DISCOLORATION AT THE APPLICATION SITES. A THERMAPAD WAS USED ON THE INCISION AFTER THE ADHESIVE WAS APPLIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335977 | DERMABOND ADVANCED TOPICAL SKIN ADHESIVE | ADHESIVE, TOPICAL SKIN | MPN | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | THERMAPAD |