MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for CLEARIT ANTI-FOG KIT PS003 manufactured by Preservation Solutions, Inc..
[141340797]
Distribution company notified preservation solutions, inc. (psi, manufacturer) on january 18, 2019 of a complaint that included an allegation from an end user that the clearit anti-fog solution kit device was not functioning as intended. The device is to be used to help prevent the fogging of endoscope lens during procedures. The allegation was that the clearit anti-fog solution did not prevent the lens from fogging during procedure. Additional follow-up information from the distributor regarding the complaint on january 21, 2019 that included information that the alleged incident took place on (b)(6) 2018 that included a statement regarding the impact of the complaint as "patient safety issue noted". Psi requested additional information regarding this statement and further information was provided from the end user via the distributor that indicated if the anti-fog solution is ineffective, time is wasted clearing the lens of fog. This would result in repeated entry into the trachea and bronchus with the endoscope which could potentially cause trauma to the airway and prolong a procedure. As of (b)(6) 2019, psi is awaiting the return of unused product from the end user/distributor for evaluation. Product lot released (b)(6) 2018 with a total quantity of (b)(4) units. All inventory from this lot has shipped from manufacturer's facility as of (b)(4) 2019. No additional complaints received by manufacturer (psi) regarding this product and/or lot number as of february 21, 2019. No additional reports of ineffective use of the device received by the manufacturer (psi) regarding this product and/or lot number as of february 21, 2019.
Patient Sequence No: 1, Text Type: N, H10
[141340798]
Distribution company notified preservation solutions, inc. (psi, manufacturer) on january 18, 2019 of a complaint that included an allegation from an end user that the clearit anti-fog solution kit device was not functioning as intended. The device is to be used to help prevent the fogging of endoscope lens during procedures. The allegation was that the clearit anti-fog solution did not prevent the lens from fogging during procedure. Additional follow-up information from the distributor regarding the complaint on january 21, 2019 that included information that the alleged incident took place on (b)(6) 2018 that included a statement regarding the impact of the complaint as "patient safety issue noted". Psi requested additional information regarding this statement and further information was provided from the end user via the distributor that indicated if the anti-fog solution is ineffective, time is wasted clearing the lens of fog. This would result in repeated entry into the trachea and bronchus with the endoscope which could potentially cause trauma to the airway and prolong a procedure. As of (b)(6) 2019, psi is awaiting the return of unused product from the end user/distributor for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000221028-2019-00113 |
| MDR Report Key | 8367379 |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-21 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2019-01-18 |
| Device Manufacturer Date | 2018-05-16 |
| Date Added to Maude | 2019-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SCOTT FISHER |
| Manufacturer Street | 1099 PROCTOR DRIVE |
| Manufacturer City | ELKHORN WI 53121 |
| Manufacturer Country | US |
| Manufacturer Postal | 53121 |
| Manufacturer Phone | 2627236715 |
| Manufacturer G1 | PRESERVATION SOLUTIONS, INC. |
| Manufacturer Street | 1099 PROCTOR DRIVE |
| Manufacturer City | ELKHORN WI 53121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLEARIT ANTI-FOG KIT |
| Generic Name | ANTI FOG SOLUTION |
| Product Code | OCT |
| Date Received | 2019-02-25 |
| Catalog Number | PS003 |
| Lot Number | PS119206 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRESERVATION SOLUTIONS, INC. |
| Manufacturer Address | 1099 PROCTOR DRIVE ELKHORN WI 53121 US 53121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-25 |