MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-22 for SIGANTURE SERIES PREFILL, 10% NBF 120ML BIO 75/CASE 561201 manufactured by Richard Allan Scientific.
| Report Number | 1831638-2019-00005 |
| MDR Report Key | 9219024 |
| Date Received | 2019-10-22 |
| Date of Report | 2019-10-22 |
| Date of Event | 2017-08-09 |
| Date Mfgr Received | 2019-09-23 |
| Date Added to Maude | 2019-10-22 |
| 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 | MICHELLE BOWERMAN |
| Manufacturer Street | 4481 CAMPUS DRIVE |
| Manufacturer City | KALAMAZOO MI 49008 |
| Manufacturer Country | US |
| Manufacturer Postal | 49008 |
| Manufacturer Phone | 2695995254 |
| Manufacturer G1 | RICHARD ALLAN SCIENTIFIC |
| Manufacturer Street | 4481 CAMPUS DRIVE |
| Manufacturer City | KALAMAZOO MI 49008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SIGANTURE SERIES PREFILL, 10% NBF 120ML BIO 75/CASE |
| Generic Name | 10% FORMALIN |
| Product Code | IFP |
| Date Received | 2019-10-22 |
| Model Number | 561201 |
| Catalog Number | 561201 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD ALLAN SCIENTIFIC |
| Manufacturer Address | 4481 CAMPUS DRIVE KALAMAZOO MI 49008 US 49008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-22 |