FDA Adverse Event
Injury
Summary report: N
APPOSE ULC 35 WIDE SKIN STAPLER
MDR report key: 2112337
·
Received May 25, 2011
Report
- Report Number
- 9610849-2011-00016
- Event Type
- Injury
- Date Received
- May 25, 2011
- Date of Event
- March 3, 2011
- Report Date
- April 29, 2011
- Manufacturer
- NELLCOR PURITAN BENNETT M
- Product Code
- GDT
- PMA / PMN Number
- K900486
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PROCEDURE TYPE: SKIN CLOSURE. ACCORDING TO THE RPTR: A PHLOGISTIC-ERYTHEMATOUS REACTION ORIGINATED ALONG THE EDGE OF THE WOUND, WITH PRESENCE OF SERUM-CORPUSCULAR SECERNMENT FROM THE APPLICATION SITE OF METALLIC CLIPS. THE PROBLEM WAS SOLVED BY REMOVING THE CLIPS AND WITH APPLICATION OF STRIPS. AS CONSEQUENCE WAS NOTIFIED AN EXTENSION OF PT HOSPITALIZATION AND SPECIFIC INTERVENTION TO REMOVE CLIPS AND VERIFY THE STATUS OF PT SKIN. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APPOSE ULC 35 WIDE SKIN STAPLER | DISPOSABLE SKIN STAPLER | GDT | NELLCOR PURITAN BENNETT M | 1007238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |