MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-09-23 for RPR CONTROL CARDS 18MM CIRCLE CONTROLS 4976709 manufactured by Becton Dickinson.
[136222]
User reported a potential exposure to the control/antigen mixture from the rpr control card kit. Due to user carelessness, there was exposure to the eye of control material that contains screened human plasma. User flushed eye with water and was examined by a dr. User is reported to be in good health. Because user is 6 weeks pregnant, a filling is being made as a precaution only, even though no malfunciton of the device is indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1999-00005 |
| MDR Report Key | 241959 |
| Report Source | 05 |
| Date Received | 1999-09-23 |
| Date of Report | 1999-08-26 |
| Date of Event | 1999-08-26 |
| Date Mfgr Received | 1999-08-26 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 1999-09-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID GATES |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RPR CONTROL CARDS 18MM CIRCLE CONTROLS |
| Generic Name | ANTISERA, CONTROL FOR NONTREPONEMAL TESTS |
| Product Code | GMP |
| Date Received | 1999-09-23 |
| Model Number | NA |
| Catalog Number | 4976709 |
| Lot Number | D903 |
| ID Number | NA |
| Device Expiration Date | 2000-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 234427 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 7 LOVETON CIR. SPARKS MD 21152 US |
| Baseline Brand Name | RPR CONTROL CARDS, IBMM CIRCLE CONTROLS |
| Baseline Generic Name | ANTISERA, CONTROL FOR NONTREPONEMAL TESTS |
| Baseline Model No | NA |
| Baseline Catalog No | 4976709 |
| Baseline ID | LOT#D903 |
| Baseline Device Family | DIRECT TESTING/SEROLOGY |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-09-23 |