MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-23 for CGH NORMAL MALE METAPHASE SLIDES 2 X 5 SLIDES 06J96-01 manufactured by Abbott Molecular, Inc..
[10298220]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20512660]
A customer reported that one slide box of the cgh normal male metaphase slides 2 x 5 slides (list number 06j96-01) had arrived with the lid open and the slides were outside of the box. One slide was broken. The customer took care when taking out the slides to avoid being injured. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[20826084]
Abbott molecular is investigating this complaint in (b)(4). Medical device report (mdr) 3005248192-2009-00003 was sent to the fda on (b)(4), 2009 for a similar issue of broken slides from pathvysion probechek slides.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2010-00001 |
| MDR Report Key | 1675910 |
| Report Source | 05 |
| Date Received | 2010-04-23 |
| Date of Report | 2010-04-12 |
| Date of Event | 2010-04-12 |
| Date Mfgr Received | 2012-10-19 |
| Date Added to Maude | 2011-03-09 |
| 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 | 0 |
| 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 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CGH NORMAL MALE METAPHASE SLIDES 2 X 5 SLIDES |
| Generic Name | MICROSCOPIC SLIDES USED IN FISH TESTING |
| Product Code | KEW |
| Date Received | 2010-04-23 |
| Catalog Number | 06J96-01 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-04-23 |