FDA Adverse Event
Malfunction
Summary report: N
KERRISON BLK COATED 130 UP 180X1MM THIN
MDR report key: 5391444
·
Received January 26, 2016
Report
- Report Number
- 2916714-2016-00045
- Event Type
- Malfunction
- Date Received
- January 26, 2016
- Report Date
- January 29, 2016
- Manufacturer
- AESCULAP AG
- Product Code
- LRY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: ON-GOING
Additional Manufacturer Narrative · 0
CORRECTION: SEE SECTION B5 FOR RELATED MED WATCH REPORTS CORRECTION: AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018
Description of Event or Problem · 0
COUNTRY OF COMPLAINT: PORTUGAL. BROKEN FOOT PLATE. REFERENCE CC/MDR # (B)(4)/00043, (B)(4)/00044, (B)(4)/00045, (B)(4)/00046, (B)(4)/00047, (B)(4)/00048.
Description of Event or Problem · 0
MULTIPLE MEDWATCH REPORTS BEING FILED THAT ARE RELATED/SIMILAR TO THIS EVENT, PLEASE SEE: 2916714-2016-00043, 2916714-2016-00044, 2916714-2016-00045, 2916714-2016-00046, 2916714-2016-00047, 2916714-2016-00048.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49487 | KERRISON BLK COATED 130 UP 180X1MM THIN | BONE PUNCHES | LRY | AESCULAP AG | FK906B | 52107119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |