MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-21 for THERMO SCIENTIFIC LABCORP HD COURIER KITS 50/CS 90001 22-038-820 manufactured by Capitol Vial Inc..
[60624073]
Based on the initial report, subsequent communication with the reporter and the product identified in the complaint, the device was not used as intended. The intended use of the device is for transport and storage of specimens, not collection of specimens. The device has not been made available to nalge nunc international or capitol vial at this time. Nalge nunc international is seeking additional information from the reporter to further the investigation.
Patient Sequence No: 1, Text Type: N, H10
[60624074]
During a procedure to obtain a urine sample, a patient alleges she incurred an injury requiring stitches due to the specimen transport and storage container.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062700-2016-00001 |
| MDR Report Key | 6119129 |
| Date Received | 2016-11-21 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-08-10 |
| Date Mfgr Received | 2016-10-25 |
| Date Added to Maude | 2016-11-21 |
| 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 | 3 |
| Manufacturer Contact | CHRISTINE EHMANN |
| Manufacturer Street | 75 PANORAMA CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14625 |
| Manufacturer Country | US |
| Manufacturer Postal | 14625 |
| Manufacturer Phone | 5858997234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERMO SCIENTIFIC LABCORP HD COURIER KITS 50/CS |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER. |
| Product Code | NNL |
| Date Received | 2016-11-21 |
| Model Number | 90001 |
| Catalog Number | 22-038-820 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAPITOL VIAL INC. |
| Manufacturer Address | AUBURN AL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-21 |