FDA Adverse Event
Injury
Summary report: N
DERMABOND 2
MDR report key: 2821475
·
Received November 6, 2012
Report
- Report Number
- 2210968-2012-07049
- Event Type
- Injury
- Date Received
- November 6, 2012
- Report Date
- October 9, 2012
- Manufacturer
- ETHICON, INC.
- Product Code
- MPN
- PMA / PMN Number
- P960052
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 A DIAGNOSTIC LAPAROSCOPY (B)(6) 2012 AND TOPICAL SKIN ADHESIVE WAS USED. THE SURGEON USED THE ADHESIVE TO CLOSE THE UMBILICAL INCISION. THE SURGEON DRIPPED IN A PUDDLE OF THE ADHESIVE AND THEN APPROXIMATED THE SKIN. THE PATIENT NOW HAS A WALNUT SIZE AREA OF INDURATION AROUND THE UMBILICUS. IT DOES NOT APPEAR TO BE INFECTED AND THERE IS NO SIGN OF HERNIA. A CT SCAN SHOWED AN INDURATION. UNSPECIFIED SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMABOND 2 | ADHESIVE, TOPICAL SKIN | MPN | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |