MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for CARDINAL HEALTH PERSONAL CLEANSING CLOTH, NON-FLUSHABLE, SCE 552AWS64 manufactured by Yangzhou Perfect Daily Chemicals.
[100773614]
The device history record could not be reviewed as a lot number was not provided. Yangzhou perfect daily chemicals reviewed all their incoming, in-process and final inspection records for their last three lot numbers manufactured and all met specification. They reviewed their skin irritation testing report and skin sensitization testing report and both met specification. As a sample was not available for further investigation, the root cause could not be determined. There is no additional action taken at this time, but yangzhou perfect daily chemicals will continue to monitor the trend of this type of incident.
Patient Sequence No: 1, Text Type: N, H10
[100773615]
The end user patient reported that wipes are causing skin irritation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2018-00159 |
| MDR Report Key | 7282578 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-02-20 |
| Date of Event | 2018-01-26 |
| Date Facility Aware | 2018-01-26 |
| Report Date | 2018-02-03 |
| Date Reported to Mfgr | 2018-02-03 |
| Date Mfgr Received | 2018-02-03 |
| Date Added to Maude | 2018-02-20 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer G1 | YANGZHOU PERFECT DAILY CHEMICALS |
| Manufacturer Street | HANGJI INDUSTRIAL PARK YANGZHOU |
| Manufacturer City | JIANGSU 225111 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 225111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARDINAL HEALTH PERSONAL CLEANSING CLOTH, NON-FLUSHABLE, SCE |
| Generic Name | PATIENT PERSONAL HYGIENE KIT |
| Product Code | NSB |
| Date Received | 2018-02-20 |
| Model Number | 552AWS64 |
| Catalog Number | 552AWS64 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YANGZHOU PERFECT DAILY CHEMICALS |
| Manufacturer Address | HANGJI INDUSTRIAL PARK YANGZHOU JIANGSU 225111 CH 225111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-20 |