MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-30 for WRIGHT'S STAIN 7547177 manufactured by Beckman Coulter, Inc..
[20215247]
A customer reported to beckman coulter inc. (bci) on (b)(4) 2011 that the wright's stain bottle was leaking at the seam there is an exposure control plan in place at the site. The damaged product was properly disposed of in biohazard drums by the lab personnel. The customer was wearing appropriate ppe. There was no exposure, or any contact to eye or skin, open wounds or mucous membranes to the wright's stain.
Patient Sequence No: 1, Text Type: D, B5
[20594997]
Replacement product was sent on (b)(4) 2011. Root cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00042 |
| MDR Report Key | 1973436 |
| Report Source | 07 |
| Date Received | 2011-01-30 |
| Date of Report | 2011-01-03 |
| Date of Event | 2011-01-03 |
| Date Mfgr Received | 2011-01-03 |
| Device Manufacturer Date | 2010-01-04 |
| Date Added to Maude | 2012-01-30 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN CULTER INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WRIGHT'S STAIN |
| Generic Name | WRIGHT"S STAIN |
| Product Code | IAF |
| Date Received | 2011-01-30 |
| Catalog Number | 7547177 |
| Lot Number | 611463 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196250 US 33196 2500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-30 |