MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-02 for STERRAD? 100 NX CASSETTE 10144 manufactured by Advanced Sterilization Products.
[186099634]
Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186099635]
A customer reported a healthcare worker (hcw) had a h202 skin reaction while removing the packaging of a sterrad? 100nx cassette and his fingers turned white. He washed the affected area with water and was seen in employee health. He stated the white marks on the finger were completely gone by the next morning and stated he was okay. This event is being reported as a malfunction report subsequent to a serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2020-40001 |
| MDR Report Key | 9775489 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495030264 |
| Manufacturer G1 | ASP IRVINE MFG |
| 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 | STERRAD? 100 NX CASSETTE |
| Generic Name | STERRAD? 100NX STERILIZER |
| Product Code | MLR |
| Date Received | 2020-03-02 |
| Catalog Number | 10144 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |