MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-25 for CUSTOM COMBI SET 03-2742-9 manufactured by Erika De Reynosa, S.a. De C.v..
| Report Number | 8030665-2019-01515 |
| MDR Report Key | 9117922 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-09-25 |
| Date of Report | 2019-11-04 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-10-31 |
| Device Manufacturer Date | 2019-07-13 |
| Date Added to Maude | 2019-09-25 |
| 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 | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM COMBI SET |
| Generic Name | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE |
| Product Code | FJK |
| Date Received | 2019-09-25 |
| Returned To Mfg | 2019-10-16 |
| Model Number | CUSTOM COMBI SET |
| Catalog Number | 03-2742-9 |
| Lot Number | 19JR01040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-25 |