FDA Adverse Event
Summary report: N
LIGACLIP*MCA MED APPLIER
MDR report key: 3102923
·
Received May 9, 2013
Report
- Report Number
- 3005075853-2013-02201
- Date Received
- May 9, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 12, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDO
- PMA / PMN Number
- K820837
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT; MDR DECISION HAS BEEN RE-RUN AND IS NOT REPORTABLE.
Description of Event or Problem · 1
RECEIVED THE PRODUCT(S) AND DURING INCOMING/LABELING OPERATION FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS UNREADABLE PRINTED LABEL (LOT# AND EXPIRATION DATE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204037 | LIGACLIP*MCA MED APPLIER | CLIP, IMPLANTABLE | GDO | ETHICON ENDO-SURGERY, LLC. | NA | K4CF1F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |