MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-10-22 for ARCHITECT SYPHILIS TP CONTROL 08D06-13 manufactured by Abbott Germany.
[126221471]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no further patient information provided due to privacy issues.
Patient Sequence No: 1, Text Type: N, H10
[126221472]
The customer reported that a male employee dropped a sample cup with architect (b)(6) control in it and some of the fluid splashed into his eye. The employee flushed his eye with water. The employee saw his physician but no additional treatment was given. The employee was not wearing any personnel protective eye wear. There was no reported impact to employee management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2018-00456 |
| MDR Report Key | 7990693 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-22 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-10-22 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT GERMANY |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT SYPHILIS TP CONTROL |
| Generic Name | SYPHILIS TP CONTROL |
| Product Code | LIP |
| Date Received | 2018-10-22 |
| Catalog Number | 08D06-13 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GERMANY |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-22 |