MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-16 for DRAINS OASIS DOUBLE 3620-100 manufactured by Atrium Medical Corporation.
[175227771]
A follow up report will be submitted upon the completion of the investigation into this event.
Patient Sequence No: 1, Text Type: N, H10
[175227772]
Report received stated that upon opening the drain a permanent kink was noticed on the patient tube. Product was not used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00083 |
| MDR Report Key | 9596524 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-03-12 |
| Date Added to Maude | 2020-01-16 |
| 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 Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAINS OASIS DOUBLE |
| Generic Name | APPARATUS, AUTOTRANSFUSION |
| Product Code | CAC |
| Date Received | 2020-01-16 |
| Model Number | 3620-100 |
| Catalog Number | 3620-100 |
| Lot Number | 443649 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL CORPORATION |
| Manufacturer Address | 40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-16 |