MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-12 for PROBECHEK MULTIVYSION CONTROL SLIDES 05J07-01 manufactured by Abbott Molecular, Inc..
[3733007]
Abbott molecular, inc. Received a complaint for probechek multivysion control slides (list (b)(4)) reporting two broken slides when the slide box was first opened. There was no report of injury. If this event were to recur, it is possible that a user could be cut by a broken slide and exposed to potentially infectious material. Therefore, recurrence of this issue could potentially cause or contribute to serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
[11376854]
A complaint investigation at abbott molecular is in progress for mdr 300524-2013-00014. An mdr follow-up report will be submitted when the complaint investigation concludes. Investigated w/o device returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2013-00014 |
| MDR Report Key | 3459846 |
| Report Source | 07 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-10-11 |
| Date of Event | 2013-10-11 |
| Date Mfgr Received | 2013-10-11 |
| Date Added to Maude | 2014-02-14 |
| 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 EAST TOUHY AVENUE |
| 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 | PROBECHEK MULTIVYSION CONTROL SLIDES |
| Generic Name | MICROSCOPIC CONTROL SLIDES |
| Product Code | MMW |
| Date Received | 2013-11-12 |
| Catalog Number | 05J07-01 |
| Lot Number | 446338 |
| Device Availability | N |
| 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 | 2013-11-12 |