MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-02-19 for CEP 6 SPECTRUMORANGE PROBE (ASR) 06J36-16 manufactured by Abbott Molecular, Inc..
[3183523]
As a customer was processing specimen slides she removed the coverslip to eliminate a bubble and cep 6 spectrumorange probe splashed into her eye. A splash in a mucous membrane with probe and potentially infectious patient sample could result in serious injury. The customer was not wearing safety glasses. The customer flushed her eye with water in accordance with the lab's procedure. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[10579093]
The material safety data sheet for dna probe in te buffer ((b)(4)) includes the following recommendations: first aid measures - general information: no specific measures required. - after eye contact: rinse opened eye for several minutes under running water. Exposure controls and personal protection: - personal protective equipment: general protective and hygienic measures: the usual precautionary measures should be adhered to general rules for handling chemicals. - eye protection: safety glasses recommended during refilling. Toxicological information - acute toxicity: - ld/lc50 values that are relevant for classification: no data available for this product. Primary irritant effect: - on the eye: no irritant effect. User error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2013-00004 |
| MDR Report Key | 2968741 |
| Report Source | 07 |
| Date Received | 2013-02-19 |
| Date of Report | 2013-01-24 |
| Date of Event | 2013-01-23 |
| Date Mfgr Received | 2013-01-23 |
| Date Added to Maude | 2013-02-20 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEP 6 SPECTRUMORANGE PROBE (ASR) |
| Generic Name | ANALYTE SPECIFIC REAGENTS, PRODUCT CODE: MVU |
| Product Code | MVU |
| Date Received | 2013-02-19 |
| Catalog Number | 06J36-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2013-02-19 |