MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-02-17 for MDI CPR MICROSHIELD 70-150 manufactured by Plasco, Inc..
[145746]
Rescuer was performing cpr on pt with an "mdi cpr" microshield. Rescuer claims that the one-way valve failed, causing saliva from pt to come in contact with the rescuer. The pt was infected with hepatitis c. The device was discarded, preventing any eval of the device to determine if it in fact malfunctioned. It is unknown at this time if the rescuer has been infected with hepatitis c.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416598-2000-00001 |
| MDR Report Key | 263486 |
| Report Source | 04 |
| Date Received | 2000-02-17 |
| Date of Report | 2000-01-25 |
| Date Mfgr Received | 2000-01-25 |
| Date Added to Maude | 2000-02-23 |
| 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 | GARY BOTSFORD QA MANAGER |
| Manufacturer Street | 3849 SWANSON CT |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8476624400 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MDI CPR MICROSHIELD |
| Generic Name | MOUTH BARRIER FOR CPR |
| Product Code | CBP |
| Date Received | 2000-02-17 |
| Model Number | NA |
| Catalog Number | 70-150 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 255073 |
| Manufacturer | PLASCO, INC. |
| Manufacturer Address | 3849 SWANSON CT GURNEE IL 60031 US |
| Baseline Brand Name | MDI CPR MICROSHIELD |
| Baseline Generic Name | MOUTH BARRIER FOR CPR |
| Baseline Model No | NA |
| Baseline Catalog No | 70-150 |
| Baseline ID | NA |
| Baseline Device Family | CPR MICROSHIELD |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K871403 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2000-02-17 |