MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-06-03 for QTEST STREP 40 TEST KIT 494776 manufactured by Becton Dickinson Microbiology Systems.
[63300]
Customer reported that tip of swab came off in patient's throat. Tip was successfully removed. No death or serious injury has occurred as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1997-00007 |
| MDR Report Key | 96373 |
| Report Source | 05,06 |
| Date Received | 1997-06-03 |
| Date of Report | 1997-05-30 |
| Date of Event | 1997-05-07 |
| Date Facility Aware | 1997-05-07 |
| Report Date | 1997-05-30 |
| Date Mfgr Received | 1997-05-07 |
| Device Manufacturer Date | 1997-02-01 |
| Date Added to Maude | 1997-06-09 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QTEST STREP 40 TEST KIT |
| Generic Name | STREP DETECTION |
| Product Code | GTY |
| Date Received | 1997-06-03 |
| Model Number | NA |
| Catalog Number | 494776 |
| Lot Number | 38004760 |
| ID Number | NA |
| Device Expiration Date | 1998-01-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 95146 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 211520999 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-03 |