MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-07 for SANI-CLOTH PLUS GERMICIDAL DISPOSABLE CLOTH manufactured by Professional Disposables International, Inc.
[101766210]
Patient Sequence No: 1, Text Type: N, H10
[101766211]
The lid on the super sani wipes container will not stay closed resulting in the container remaining open and the wipes dry out quickly causing them not to provide adequate dwell time for disinfection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7320713 |
| MDR Report Key | 7320713 |
| Date Received | 2018-03-07 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-02-16 |
| Report Date | 2018-02-16 |
| Date Reported to FDA | 2018-02-16 |
| Date Reported to Mfgr | 2018-02-16 |
| Date Added to Maude | 2018-03-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANI-CLOTH PLUS GERMICIDAL DISPOSABLE CLOTH |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2018-03-07 |
| Lot Number | A11701401 |
| Device Expiration Date | 2019-10-01 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROFESSIONAL DISPOSABLES INTERNATIONAL, INC |
| Manufacturer Address | 2 NICE PAK PARK ORANGEBURG NY 10962 US 10962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-07 |