MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-03 for AMIES MODIFIED MEDIUM, SINGLE SWAB PDC-100 manufactured by Precision Dynamics Corp..
[14048]
Collection and transport system swabs used for collection of microbiology specimens are contaminated with non-viable bacteria (gram negative rods). Upon gram stain of the swab previously immersed in the holding medium, gram negative rods are visible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005323 |
| MDR Report Key | 20129 |
| Date Received | 1995-03-03 |
| Date of Report | 1995-02-28 |
| Date of Event | 1995-02-23 |
| Date Added to Maude | 1995-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMIES MODIFIED MEDIUM, SINGLE SWAB |
| Generic Name | SWABS |
| Product Code | JSC |
| Date Received | 1995-03-03 |
| Model Number | PDC-100 |
| Lot Number | 029, 056, 172 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 20016 |
| Manufacturer | PRECISION DYNAMICS CORP. |
| Manufacturer Address | VAN NUYS CA 91409 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-03-03 |