MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for CURAPLEX POM 301-0318LT manufactured by Tri-anim Health Services, Inc..
[110224451]
Patient Sequence No: 1, Text Type: N, H10
[110224452]
Could not get oxygen reading on patient. No hole in o2 connection on mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7572983 |
| MDR Report Key | 7572983 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-25 |
| Report Date | 2018-05-29 |
| Date Reported to FDA | 2018-05-29 |
| Date Reported to Mfgr | 2018-05-29 |
| Date Added to Maude | 2018-06-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | CURAPLEX POM |
| Generic Name | ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE |
| Product Code | BYE |
| Date Received | 2018-06-06 |
| Catalog Number | 301-0318LT |
| Lot Number | 022218-022221 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRI-ANIM HEALTH SERVICES, INC. |
| Manufacturer Address | P.O. BOX 8023 DUBLIN OH 430162023 US 430162023 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-06 |