ELEFANT SUCTION-IRRIGATION DEVICE
Report
- Report Number
- 9610711-2023-00187
- Event Type
- Malfunction
- Date Received
- August 24, 2023
- Report Date
- January 15, 2024
- Manufacturer
- COLOPLAST A/S
- Product Code
- FQH
- UDI-DI
- 03600040320501
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN¿T FIND OTHER COMPLAINT ON THE LOT NUMBER 801131. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. ON JULY WE RECEIVED ONE SEALED SAMPLE. AFTER OBSERVATION WE NOTED THAT A HAIR WAS INSIDE THIS PACKAGING. ON OCTOBER, A RESENSITIZATION WAS PERFORMED IN THE ELEFANT AREA IN THE WORKSHOP WITH THE OPERATORS CONCERNED (SEE IN INVESTIGATION THE PROOF OF RESENSITIZATION).
WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A FOREIGN MATERIAL IN THE PRIMARY PACKAGING. THE MATERIAL WAS FOUND BEFORE THE PACKAGE WAS OPENED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A FOREIGN MATERIAL IN THE PRIMARY PACKAGING. THE MATERIAL WAS FOUND BEFORE THE PACKAGE WAS OPENED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2122308 | ELEFANT SUCTION-IRRIGATION DEVICE | SURGICAL IRRIGATION/ASPIRATION CANNULA, NON-ILLUMINATING, SINGLE-USE | FQH | COLOPLAST A/S | 8011314_ASP1901002 | 03600040320501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |