MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-26 for ELECSYS SYSCLEAN 11298500160 manufactured by Roche Diagnostics.
[2949453]
The customer was injured when the sysclean solution splashed onto her face. She was starting maintenance and was preparing to put the sysclean into a microcup. She wiped the tip of the sysclean squirt bottle and then squirted the sysclean upside down and at an angle into the cup. The tip came off of the bottle and the sysclean splashed up. The customer turned her head and the solution hit the side of her face and ran down towards her neck. The customer grabbed some paper towels and then went to a sink and ran water on it her face for about 10 minutes. It was still burning after the 10 minutes so she rinsed it for 20 minutes more. She stated it was still really burning, so she went to the er. By the time she got to the er, she had the open sore on her face. The customer was given keflex and a cream to keep her skin moist. On (b)(6) 2012, the customer was examined by a plastic surgeon. The plastic surgeon debrided the area and prescribed antibiotics as he thought it might be infected. The lot number of the sysclean solution was not provided. The bottle was disposed of after the incident. The only personal protective equipment being worn by the customer was gloves. No glasses or lab coat were worn.
Patient Sequence No: 1, Text Type: D, B5
[10252494]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[10522091]
No other complaints have been received regarding the tip coming off of a sysclean bottle. This shows the issue could not have been caused by a general or lot specific defect of the bottle. Product labeling instructs the user to wear suitable protective clothing, gloves and eye/face protection.
Patient Sequence No: 1, Text Type: N, H10
[10746404]
The precautions and warnings section of the product labeling has been updated to include additional information for the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-05426 |
| MDR Report Key | 2806715 |
| Report Source | 05,06 |
| Date Received | 2012-10-26 |
| Date of Report | 2013-06-18 |
| Date of Event | 2012-10-09 |
| Date Mfgr Received | 2012-10-12 |
| Date Added to Maude | 2012-10-26 |
| 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 | ELECSYS SYSCLEAN |
| Generic Name | SODIUM HYDROXIDE,SODIUM HYPOCHLORITE SOLUTION |
| Product Code | JCB |
| Date Received | 2012-10-26 |
| Model Number | NA |
| Catalog Number | 11298500160 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2012-10-26 |