MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-13 for KIT CWS I/NAOH-D/BASIC WASH 04880285190 manufactured by Roche Diagnostics.
[3246129]
While replacing the naoh-d (cell wash 1) solution on the modular core analyzer, serial number (b)(4), the customer was kneeling on the floor and was pouring liquid from one bottle to another. The bottle slipped from her hands and the solution splashed in her face. The customer stated there were no issues with the bottle. The customer had first degree burns to face and right eye and was treated in the emergency room. The emergency room flushed the affected areas with cold water and treated her with ointment for face and eye. The customer's current condition was "fully healed". The customer was wearing contacts when the incident occurred, but was not wearing any personal protective equipment.
Patient Sequence No: 1, Text Type: D, B5
[10289016]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[10576307]
The investigation determined the cause of the event was a customer handling error. Product labeling instructs the customer not to pool solutions together. Also, protective clothing and equipment such as safety gloves or glasses should be worn when working in a laboratory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-06312 |
| MDR Report Key | 2871408 |
| Report Source | 05,06 |
| Date Received | 2012-12-13 |
| Date of Report | 2013-02-25 |
| Date of Event | 2012-11-29 |
| Date Mfgr Received | 2012-11-29 |
| Date Added to Maude | 2012-12-13 |
| 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 | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIT CWS I/NAOH-D/BASIC WASH |
| Generic Name | SODIUM HYROXIDE SOLUTION |
| Product Code | JCB |
| Date Received | 2012-12-13 |
| Model Number | NA |
| Catalog Number | 04880285190 |
| Lot Number | 10209700 |
| ID Number | NA |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-13 |