MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2009-12-10 for PARAFFIN PRETREATMENT KIT II AND KIT III 7J02-02 manufactured by Abbott Molecular, Inc..
[1451795]
An internal investigation has identified that the paraffin pretreatment reagent kit ii and paraffin pretreatment reagent iii did not have any hazard or msds information included in their labeling. Appropriate symbology for hazardous and corrosive material has not been included on the vial label, kit label and package insert. An abbott molecular employee discovered this labeling issue. The paraffin pretreatment reagent kit ii were 420563, 420008, 418294. The paraffin pretreatment reagent kit iii lots were 420063 and 418669.
Patient Sequence No: 1, Text Type: D, B5
[8347461]
Additional information for lot # 7j02-03. A field correction in the form of a customer letter and a telephone protocol will be developed to inform the customers of this labeling issue for the paraffin pretreatment reagent kit ii and paraffin pretreatment kit iii. No complaints from customers have been reported due to this issue. The date of event is when abbott molecular decided to take a field action and inform customers of this labeling issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2009-00005 |
| MDR Report Key | 1559647 |
| Report Source | 00,07 |
| Date Received | 2009-12-10 |
| Date of Report | 2009-12-10 |
| Date of Event | 2009-11-13 |
| Date Mfgr Received | 2009-11-13 |
| Date Added to Maude | 2011-04-04 |
| 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 | PAULA MARTIN |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617333 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARAFFIN PRETREATMENT KIT II AND KIT III |
| Generic Name | NONE |
| Product Code | KEO |
| Date Received | 2009-12-10 |
| Model Number | 7J02-02 |
| Lot Number | 420563 |
| ID Number | SEE EVENT SECTION |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-10 |