MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-12-08 for CIDEX ACTIVATED DIALDEHYDE SOLUTION SCX145 manufactured by Advanced Sterilization Products.
[61848851]
Advanced sterilization products (asp) has requested additional information regarding this 2002 publication and event, including cidex? Part and lot numbers, but has received nothing further to date. Furthermore, asp is unable to confirm if this event was captured in a previous complaint. Based on this limited information, a decision was made to file a fda medwatch report. The details of the injury are unknown; however, asp has decided to report this event out of an abundance of caution, and due to the fact that cidex was mentioned. Further investigation is being done, and this complaint will be re-assessed if new information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[61848852]
This event is being reported based on a literature review of pubmed id 27740306. The title is? Unions welcome cidex? Withdrawal,? And was published in print in the? News? Section of nursing standard from the united kingdom in january 2002. The website link is as follows: http://dx. Doi. Org/10. 7748/ns. 16. 20. 8. S20. In this news article, it was reported? Healthcare unions have welcomed the withdrawal from the market of the glutaraldehyde disinfectant, cidex??. It was also reported cidex? Was to be taken off the market on may 1st, 2002, and would be replaced with cidex? Opa. Lastly, it reported staff developed asthma and skin problems linked to cidex? ; and one health care worker (hcw) developed? Asthma that was linked to her use of the product to sterilise instruments?.
Patient Sequence No: 1, Text Type: D, B5
[68244359]
Asp investigation summary: the investigation included a review of the batch history record, complaint trending, visual analysis, functional analysis and retains analysis. The batch history record could not be reviewed as the lot number was not available. Complaint trending could not be performed as the issue was not isolated to a specific lot or lots. The sra indicates the risk associated with exposure toxic or corrosive material is "low. " visual analysis was not performed as the product was not available for return. The supplier was not notified of the issue was not identified as a manufacturing or functional issue. Retains testing was not performed as the issue was not isolated to a specific lot or lots. The assignable cause of this issue could not be verified. Multiple attempts to obtain additional information were unsuccessful. The issue will continue to be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2084725-2016-00757 |
| MDR Report Key | 6156822 |
| Report Source | LITERATURE |
| Date Received | 2016-12-08 |
| Date of Report | 2016-11-15 |
| Date of Event | 2012-01-30 |
| Date Mfgr Received | 2017-02-13 |
| Date Added to Maude | 2016-12-08 |
| 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 | 3 |
| Manufacturer Contact | JOAQUIN KURZ |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIDEX ACTIVATED DIALDEHYDE SOLUTION |
| Generic Name | BIOCIDES SOLUTIONS (LRJ) |
| Product Code | LRJ |
| Date Received | 2016-12-08 |
| Model Number | NA |
| Catalog Number | SCX145 |
| Lot Number | UNK |
| 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 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-08 |