MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-09-09 for PRODUCT CODE 901012 PARA-PAK ZN-PVA manufactured by Meridian Bioscience, Inc..
[18584130]
Meridian bioscience, was contacted about a hospitalized pt. While in the hospital, the pt was given one 15ml vial of the stool transport medium para-pak zn-pva in order to collect stool. The pt instead drank part or all of the contents of the vial. After drinking the contents they vomitted green bile and mucous. They were given milk of magnesia by the hosp staff. After vomiting the pt was asymptomatic and able to consume food and liquids. Incident occurred at approx 10:30pm in 2004. It was reported to the poison control center at 8:00am on the following day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1524213-2004-00001 |
| MDR Report Key | 543334 |
| Report Source | 06 |
| Date Received | 2004-09-09 |
| Date of Report | 2004-09-09 |
| Date of Event | 2004-08-05 |
| Date Mfgr Received | 2004-08-05 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2004-09-15 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 3471 RIVER HILLS DR |
| Manufacturer City | CINCINNATI OH 45244 |
| Manufacturer Country | US |
| Manufacturer Postal | 45244 |
| Manufacturer Phone | 5132713700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRODUCT CODE 901012 PARA-PAK ZN-PVA |
| Generic Name | STOOL COLLECTION, PRESERVATION & COLLECTION DEVICE |
| Product Code | LDX |
| Date Received | 2004-09-09 |
| Model Number | NA |
| Catalog Number | 901012 |
| Lot Number | 731330 |
| ID Number | NA |
| Device Expiration Date | 2006-05-31 |
| 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 | 532711 |
| Manufacturer | MERIDIAN BIOSCIENCE, INC. |
| Manufacturer Address | * CINCINNATI OH 45244 US |
| Baseline Brand Name | PARA-PAK ZN-PVA |
| Baseline Generic Name | FIXATIVE, METALLIC CONTAINING |
| Baseline Model No | 901012 |
| Baseline Catalog No | 901012 |
| Baseline ID | NONE |
| Baseline Device Family | PARA-PAK |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-09 |