FDA Adverse Event
Other
Summary report: N
ASPEN REINFORCED SKIN CLOSURE
MDR report key: 2987905
·
Received February 21, 2013
Report
- Report Number
- 1836161-2013-00014
- Event Type
- Other
- Date Received
- February 21, 2013
- Date of Event
- February 1, 2010
- Report Date
- February 21, 2013
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- FPX
- PMA / PMN Number
- K874813
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL - METHOD: SAMPLES WERE RETURNED. DOCUMENTATION WAS REVIEWED. RESULTS: NO FAILURE COULD BE DETERMINED. CONCLUSION: NO ROOT CAUSE COULD BE DETERMINED.
Description of Event or Problem · 1
STRIPS ARE ADHERING TO PATIENT SO MUCH THAT IT IS COMPROMISING THE TISSUE WHEN THE STRIPS ARE PULLED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75216 | ASPEN REINFORCED SKIN CLOSURE | SKIN CLOSURE- REINFORCED | FPX | ASPEN SURGICAL PRODUCTS, INC. | 2009-11-06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |