MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-01 for PROBECHEK PATHVYSION HER-2/NEU NORMAL CONTROL 02J05-030 manufactured by Abbott Molecular, Inc..
[1173882]
A customer reported that probechek pathvysion control slides that were shipped were broken upon arrival. The plastic case housing the probechek pathvysion control slides had popped open. The customer stated two problems with the box's contents: heavy reagents were on top of the probechek slides, no cushion wrap was used around the slides during shipment. The slides were broken. Customer stated that a person could have cut themselves due to the glass shards. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8284172]
Abbott molecular at this time believes that this incident is a packaging error - i. E. , the customer reported that no packaging material was used to wrap the box of the probechek slides for the pathvysion her-2/neu assay. The review of the operating procedures for the packaging of the slides was completed and determined that only cold storage boxes of slides are cushioned wrapped, but not for ambient shipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2009-00003 |
| MDR Report Key | 1497200 |
| Report Source | 05 |
| Date Received | 2009-09-01 |
| Date of Report | 2009-08-31 |
| Date of Event | 2009-08-04 |
| Date Mfgr Received | 2009-08-04 |
| Date Added to Maude | 2010-08-19 |
| 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 | 3 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBECHEK PATHVYSION HER-2/NEU NORMAL CONTROL |
| Generic Name | MICROSCOPIC SLIDES USED IN FISH TESTING |
| Product Code | KIR |
| Date Received | 2009-09-01 |
| Catalog Number | 02J05-030 |
| Lot Number | TBD |
| 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 | 2009-09-01 |