FDA Adverse Event
Injury
Summary report: N
DERMABOND* PROPEN TOPICAL SKIN ADHESIVE
MDR report key: 4203579
·
Received October 27, 2014
Report
- Report Number
- 2210968-2014-14997
- Event Type
- Injury
- Date Received
- October 27, 2014
- Date of Event
- August 11, 2014
- Report Date
- October 7, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- MPN
- PMA / PMN Number
- K100423
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON REPAIR ON AN UNKNOWN DATE AND A TOPICAL SKIN ADHESIVE WAS USED. THREE WEEKS POST OPERATIVE THE PATIENT DEVELOPED A REACTION AT THE SITE. THE REACTION SUBSIDED 2 MONTHS AFTER AN UNSPECIFIED INTERVENTION WAS INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 681966 | DERMABOND* PROPEN TOPICAL SKIN ADHESIVE | ADHESIVE, TOPICAL SKIN | MPN | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |