PROGEL PLATINUM PLEURAL AIR LEAK SEALANT
Report
- Report Number
- 1213643-2022-00773
- Event Type
- Injury
- Date Received
- December 2, 2022
- Date of Event
- November 1, 2022
- Report Date
- September 4, 2024
- Manufacturer
- NEOMEND INC -2953195
- Product Code
- NBE
- UDI-DI
- 00801741010040
- PMA / PMN Number
- P010047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THERE IS NO CONNECTION THAT COULD BE IDENTIFIED BETWEEN THE USE OF THE PROGEL PLATINUM AND THE PATIENTS REPORTED POSTOPERATIVE COMPLICATION. PNEUMONIA IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT IN LUNG SURGERY. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THIS MDR REPRESENTS THE REPORTED POSTOPERATIVE COMPLICATION OF PATIENT #1. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS (B)(6) 2022 BASED ON THE INFORMATION PROVIDED. THE SUBJECT PRODUCT PROGEL PLATINUM IS NOT MARKETED FOR US SALES. A SIMILAR PRODUCT PROGEL IS MARKETED IN THE US. THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THERE IS NO CONNECTION THAT COULD BE IDENTIFIED BETWEEN THE USE OF THE PROGEL PLATINUM AND THE PATIENTS REPORTED POSTOPERATIVE COMPLICATION. PNEUMONIA IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT IN LUNG SURGERY. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THIS MDR REPRESENTS THE REPORTED POSTOPERATIVE COMPLICATION OF PATIENT #1. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS 01-NOV-2022 BASED ON THE INFORMATION PROVIDED. THE SUBJECT PRODUCT PROGEL PLATINUM IS NOT MARKETED FOR US SALES. A SIMILAR PRODUCT PROGEL IS MARKETED IN THE US. H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT MEDICAL DEVICE MANUFACTURER. UPDATED FIELDS: B4, D4 (UDI NO.), G3, G6, H2, H10, H11. CORRECTED FIELD: D3 (MEDICAL DEVICE MANUFACTURER), G4. NOTE: SECTION A THROUGH F THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
AS REPORTED PER SALES REP: SALES REP VISITED THE FACILITY AND SPOKE WITH THE SURGEON WHO STATED THAT SHE HAD USED PROGEL PLATINUM ON SEVERAL OCCASIONS (NO EXACT NUMBER). SURGEON STATED THAT IN THE POSTOPERATIVE COMPLICATIONS, THREE PATIENTS PRESENTED WITH PURULENT PNEUMOPATHY. THE ONLY COMMON DENOMINATOR THAT SHE FOUND IN THESE 3 CASES WAS THE USE OF PROGEL PLATINUM, NEVERTHELESS SHE DID NOT INCRIMINATE THE PRODUCT BUT WONDERED. MOREOVER, SHE INFORMED ME THAT HER COLLEAGUES AT THE CLINIC HAD NOT HAD THIS KIND OF PROBLEM.
AS REPORTED PER SALES REP: SALES REP VISITED THE FACILITY AND SPOKE WITH THE SURGEON WHO STATED THAT SHE HAD USED PROGEL PLATINUM ON SEVERAL OCCASIONS (NO EXACT NUMBER). SURGEON STATED THAT IN THE POSTOPERATIVE COMPLICATIONS, THREE PATIENTS PRESENTED WITH PURULENT PNEUMOPATHY. THE ONLY COMMON DENOMINATOR THAT SHE FOUND IN THESE 3 CASES WAS THE USE OF PROGEL PLATINUM, NEVERTHELESS SHE DID NOT INCRIMINATE THE PRODUCT BUT WONDERED. MOREOVER, SHE INFORMED ME THAT HER COLLEAGUES AT THE CLINIC HAD NOT HAD THIS KIND OF PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347190 | PROGEL PLATINUM PLEURAL AIR LEAK SEALANT | SEALANT, POLYMERIZING | NBE | NEOMEND INC -2953195 | NA | NI | 00801741010040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |