MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-03 for ACL TOP 500 CTS 2800-40 00000280040 manufactured by Instrumentation Laboratory.
| Report Number | 1217183-2019-00004 |
| MDR Report Key | 8956671 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-09-03 |
| Date of Report | 2019-09-03 |
| Date of Event | 2019-08-11 |
| Date Mfgr Received | 2019-08-12 |
| Device Manufacturer Date | 2013-11-06 |
| Date Added to Maude | 2019-09-03 |
| 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 | MS. REBA DAOUST |
| Manufacturer Street | 180 HARTWELL ROAD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7818614597 |
| Manufacturer G1 | INSTRUMENTATION LABORATORY |
| Manufacturer Street | 180 HARTWELL ROAD |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACL TOP 500 CTS |
| Generic Name | INSTRUMENT, COAGULATION, AUTOMATED, PRODUCT CODE: GKP |
| Product Code | GKP |
| Date Received | 2019-09-03 |
| Model Number | 2800-40 |
| Catalog Number | 00000280040 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTRUMENTATION LABORATORY |
| Manufacturer Address | 180 HARTWELL ROAD BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-03 |