MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,literature,study,use report with the FDA on 2015-08-08 for PROD TEST BRAND M12345 C12345 manufactured by Abbott Diabetes Care Inc..
[22370867]
Adding text at point of redaction - then redacting.
Patient Sequence No: 1, Text Type: N, H10
[22370868]
Redacting in prod
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2015-11111 |
| MDR Report Key | 4987491 |
| Report Source | CONSUMER,LITERATURE,STUDY,USE |
| Date Received | 2015-08-08 |
| Date of Report | 2015-08-08 |
| Date of Event | 2015-08-08 |
| Date Facility Aware | 2014-08-08 |
| Report Date | 2015-08-08 |
| Date Reported to FDA | 2015-08-01 |
| Date Reported to Mfgr | 2015-08-01 |
| Date Added to Maude | 2015-08-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VAIBHAV PRADHAN |
| Manufacturer Street | 1360 SOUTH LOOP RD. |
| Manufacturer City | ALAMEDA CA 94502 |
| Manufacturer Country | US |
| Manufacturer Postal | 94502 |
| Manufacturer G1 | ABBOTT DIABETES CARE INC. |
| Manufacturer Street | 1360 SOUTH LOOP RD. |
| Manufacturer City | ALAMEDA CA 94502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94502 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROD TEST BRAND |
| Generic Name | PROD DEVICE TYOE |
| Product Code | DFD |
| Date Received | 2015-08-08 |
| Model Number | M12345 |
| Catalog Number | C12345 |
| Lot Number | L12345 |
| ID Number | O12345 |
| Device Expiration Date | 2016-01-01 |
| Operator | NO INFORMATION |
| Device Availability | * |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETES CARE INC. |
| Manufacturer Address | 1360 SOUTH LOOP RD. 1006 ALAMEDA CA 94502 US 94502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Life Threatening | 2015-08-08 |