FDA Adverse Event
Malfunction
Summary report: N
D-ANEURYSM MINI CLIP TITANIUM PERMANENT
MDR report key: 19069645
·
Received April 9, 2024
Report
- Report Number
- 8010890-2024-00001
- Event Type
- Malfunction
- Date Received
- April 9, 2024
- Date of Event
- March 1, 2024
- Report Date
- April 9, 2024
- Manufacturer
- PETER LAZIC GMBH MICROSURGICAL INNOVATIONS
- Product Code
- HCH
- UDI-DI
- 04250603731665
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE CASE IS CURRENTLY BEING INVESTIGATED.
Description of Event or Problem · 0
OUR CUSTOMER HAS INFORMED US THAT WHEN THE DOCTOR OPENED THE BOX OF S.35.714, THERE WAS A PRODUCT THAT DID NOT MATCH THE CATALOG SPECIFICATIONS. IT SUPPOSED TO BE A STRONG CURVE, BUT THE PRODUCT IN THE BOX HAD A WEAK CURVE. WOULD YOU PLEASE LET US KNOW THE CAUSE OF THE PROBLEM AND MEASURES TP PREVENT FUTURE REOCCURRENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513573 | D-ANEURYSM MINI CLIP TITANIUM PERMANENT | CLIP, ANEURYSM | HCH | PETER LAZIC GMBH MICROSURGICAL INNOVATIONS | S.35.714 | 04250603731665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |