MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for SOCLEAN2 CARTRIDGE FILTER KIT PN1207 manufactured by Soclean, Inc..
[119023975]
Replacement check-valve for soclean 2 (model sc1200 cpap sanitizer) defective. A few days after replacing filter and check valve, i noticed leakage all over my night stand. In fact, cpap cord got so wet that it stopped working. Check-valve literally fell apart when i removed it. Looking at the check valve, it is obvious that there was an incomplete seal holding the valve together (both ends). After i got my cpap cried out, i replaced the check valve again with another brand new one. (both kits were purchased at the same time). The second one also leaked. I called soclean, where i was told they could not send me replacement valves, but would sell me new kits at a discount. I refused. Soclean rep acknowledged this is a known issue, where they suspect parts provided by soclean through (b)(6) may have come from an unauthorized source. I have photos if you would like, or can send both valves. I still have the packaging materials for the second kit, though i do not see a lot number anywhere. It is id'd as "mfg. Pn1207. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079485 |
| MDR Report Key | 7832239 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-20 |
| Date Added to Maude | 2018-08-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOCLEAN2 CARTRIDGE FILTER KIT |
| Generic Name | DISINFECTANT MEDICAL DEVICE |
| Product Code | LRJ |
| Date Received | 2018-08-29 |
| Model Number | PN1207 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOCLEAN, INC. |
| Brand Name | SOCLEAN2 CARTRIDGE FILTER KIT |
| Generic Name | DISINFECTANT MEDICAL DEVICE |
| Product Code | LRJ |
| Date Received | 2018-08-29 |
| Model Number | 1200 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SOCLEAN, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |