MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-06-15 for CIDEX REGULAR 4.7 LITER 2266 manufactured by Advanced Sterilization Products.
[111212957]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[111212958]
Advanced sterilization products (asp) became aware a patient tested (b)(6) for (b)(6) and was diagnosed in (b)(6) 2013 with acquired immune deficiency syndrome. It was reported a colonoscopy procedure was performed in (b)(6) 2011, using an olympus colonoscope (non-asp product) which was reprocessed in cidex solution. On (b)(6) 2004 (revised on (b)(6) 2004), ats labs prepared protocol # (b)(6) for asp, titled? Virucidal efficacy of disinfectants for use on inanimate environmental surfaces? Virus: (b)(6) type 1?. The conclusion of this study was that cidex demonstrated complete inactivation of (b)(6) type 1 as required by the united states (b)(4) for virucidal label claims. Asp made a decision to file a fda medwatch report out of an abundance of caution; however, asp does not believe the patient diagnosis was related to use of cidex during scope reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2018-00635 |
| MDR Report Key | 7606148 |
| Report Source | OTHER |
| Date Received | 2018-06-15 |
| Date of Report | 2018-05-23 |
| Date of Event | 2013-07-22 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2018-06-15 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| 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 REGULAR 4.7 LITER |
| Generic Name | BIOCIDES SOLUTIONS |
| Product Code | LRJ |
| Date Received | 2018-06-15 |
| Catalog Number | 2266 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Deathisabilit | 2018-06-15 |