FDA Adverse Event
Injury
Summary report: N
DERMABOND ADVANCED TOPICAL SKIN ADHESIVE
MDR report key: 3994403
·
Received August 8, 2014
Report
- Report Number
- 2210968-2014-11003
- Event Type
- Injury
- Date Received
- August 8, 2014
- Report Date
- July 22, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- MPN
- PMA / PMN Number
- K100423
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT PACEMAKER SURGERY IN (B)(6) 2014 AND A TOPICAL SKIN ADHESIVE WAS USED. POST PROCEDURE, THE PATIENT DEVELOPED UNRESOLVED ALLERGIC CONTACT DERMATITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470827 | DERMABOND ADVANCED TOPICAL SKIN ADHESIVE | ADHESIVE, TOPICAL SKIN | MPN | ETHICON INC. | UNK | GLP416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |