MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-08-15 for DOLPHIN FIS DLPH-35820000J-M manufactured by Joerns Healthcare.
| Report Number | 3009402404-2019-00052 |
| MDR Report Key | 8898717 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-08-15 |
| Date of Report | 2019-08-15 |
| Date of Event | 2019-07-16 |
| Date Mfgr Received | 2019-08-15 |
| Date Added to Maude | 2019-08-15 |
| 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 | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Manufacturer G1 | JOERNS HEALTHCARE |
| Manufacturer Street | AVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL |
| Manufacturer City | MATAMOROS,, 87499 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 87499 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOLPHIN FIS |
| Generic Name | PATIENT AIR MATTRESS |
| Product Code | FNM |
| Date Received | 2019-08-15 |
| Returned To Mfg | 2019-08-08 |
| Model Number | DLPH-35820000J-M |
| Catalog Number | DLPH-35820000J-M |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOERNS HEALTHCARE |
| Manufacturer Address | AVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL MATAMOROS,, 87499 MX 87499 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-15 |