FDA Adverse Event
Injury
Summary report: N
LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E
MDR report key: 8964553
·
Received September 5, 2019
Report
- Report Number
- 3005180920-2019-00752
- Event Type
- Injury
- Date Received
- September 5, 2019
- Date of Event
- August 9, 2019
- Report Date
- September 5, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030807671
- PMA / PMN Number
- K103352
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2019. LOT 172716: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2017. EXPIRATION DATE: 2022-08-18. NO ANOMALIES FOUND.
Description of Event or Problem · 1
REVISION SURGERY WHERE THE SURGEON WANTS TO CHANGE THE LINER TO A HOODED ONE. AT THE MOMENT NO MORE INFORMATIONS ARE AVAILABLE CONCERNING THE SURGERY DATE AND THE OUTCOMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 759775 | LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E | FLAT PE HC LINER | LZO | MEDACTA INTERNATIONAL SA | 172716 | 07630030807671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |