MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-06 for BACTERIOLOGICAL SPECIMEN COLLECTION TRANSPORT SYSTEM manufactured by Precision Dynamics Corp..
[19855]
The culture sponge at the end of the tube got stuck on the end of the swab. Same incident occurred in 11/94 wherein a 3-yr old pt getting a routine throat culture continued to gag well after the swab was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000831 |
| MDR Report Key | 27054 |
| Date Received | 1995-10-06 |
| Date of Report | 1995-01-27 |
| Date of Event | 1994-11-01 |
| Date Added to Maude | 1995-10-16 |
| 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 |
| 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 | BACTERIOLOGICAL SPECIMEN COLLECTION TRANSPORT SYSTEM |
| Generic Name | BACTERIOLOGCIAL SPECIMEN COLLECTION |
| Product Code | JSC |
| Date Received | 1995-10-06 |
| Lot Number | 021 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27849 |
| Manufacturer | PRECISION DYNAMICS CORP. |
| Manufacturer Address | SAN FERNANDO CA 913403490 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-10-06 |