FDA Adverse Event
Other
Summary report: N
RICHARD ALLEN SURGICAL NEEDLE
MDR report key: 2987948
·
Received February 22, 2013
Report
- Report Number
- 1836161-2013-00068
- Event Type
- Other
- Date Received
- February 22, 2013
- Date of Event
- August 24, 2011
- Report Date
- February 22, 2013
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- GAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DUE TO A RECENT (B)(4) INSPECTION, THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION. STRENGTH AND HARDNESS TESTS PERFORMED ON A RESERVE SAMPLE FROM THE SAME LOT. REVIEW OF THE DHR ALSO PERFORMED. NO FAILURES DETECTED. POTENTIAL CAUSE RELATED TO HOW IT IS HANDLED.
Description of Event or Problem · 1
CUSTOMER STATES THAT NEEDLE BROKE IN TWO PLACES DURING SURGERY, BUT PT WAS NOT AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77857 | RICHARD ALLEN SURGICAL NEEDLE | EYED SURGICAL NEEDLE | GAB | ASPEN SURGICAL PRODUCTS, INC. | 2016-02-21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |