MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-10-24 for VYSIS TELVYSION 9P SPECTRUMGREEN PROBE 05J03-009 manufactured by Abbott Molecular, Inc..
[2947205]
A customer in (b)(6) received broken probe and hybridization buffer vials in the vysis telvysion 9p spectrumgreen probe kit. There was no damage to the external packaging. The end user was not hurt since the broken pieces were contained in the plastic bag and was not exposed to the contents of the vials because there was no leakage from the plastic bag.
Patient Sequence No: 1, Text Type: D, B5
[10243733]
Per the certificate of analysis for the vysis telvysion 9p spectrumgreen probe, the hybridization buffer is classified as toxic and an irritant. It is possible for users to be cut or have their gloves torn by broken vials, exposing them to the vial contents and the biohazardous lab environment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2012-00024 |
| MDR Report Key | 2802786 |
| Report Source | 07 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-09-24 |
| Date of Event | 2012-09-24 |
| Date Mfgr Received | 2012-09-24 |
| Date Added to Maude | 2013-02-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEAN LEETE |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VYSIS TELVYSION 9P SPECTRUMGREEN PROBE |
| Generic Name | ANALYTE SPECIFIC REAGENTS |
| Product Code | MVU |
| Date Received | 2012-10-24 |
| Catalog Number | 05J03-009 |
| Lot Number | 437582 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-24 |