MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-07-24 for ALPHA RESPONSE 465001DAR manufactured by Arjohuntleigh Polska Sp Z O.o.
| Report Number | 3007420694-2019-00119 |
| MDR Report Key | 8820958 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-07-24 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-06-24 |
| Date Mfgr Received | 2019-06-27 |
| Device Manufacturer Date | 2012-06-18 |
| Date Added to Maude | 2019-07-24 |
| 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 | KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHA RESPONSE |
| Generic Name | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
| Product Code | FNM |
| Date Received | 2019-07-24 |
| Model Number | 465001DAR |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Address | KS. WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-24 |