MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for HOPKINS MEDICAL PRODUCTS? PDI SANI-CLOTH AF3 692965 manufactured by Hopkins Uniform Company.
[134315673]
Mold growing in sani-wipes container when seal initially removed. It was only the one container so far. The manufacturer rep has also been notified and is meeting with infection control this week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8284358 |
| MDR Report Key | 8284358 |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-25 |
| Date of Event | 2019-01-18 |
| Report Date | 2019-01-25 |
| Date Reported to FDA | 2019-01-25 |
| Date Reported to Mfgr | 2019-01-29 |
| Date Added to Maude | 2019-01-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HOPKINS MEDICAL PRODUCTS? PDI SANI-CLOTH AF3 |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2019-01-29 |
| Model Number | 692965 |
| Catalog Number | 692965 |
| Lot Number | 23:19 280 03 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOPKINS UNIFORM COMPANY |
| Manufacturer Address | 6850 SOUTHBELT DRIVE CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |