MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-31 for HOPKINS MEDICAL PRODUCTS? SANI-CLOTH BLEACH 692965 manufactured by Hopkins Uniform Company.
[146636594]
Multiple staff with their finger stuck into opening of lid to thread wipes and fingers have been pinched and difficult to remove from lid. Design is not user friendly. While pushing new bleach wipe through teeth, staff finger was stuck. As staff was trying to pull finger out, the rigid teeth pressed deeply into finger, causing some swelling and pain. Another staff member had to assist with removal by cutting the teeth with scissors to prevent further injury. Multiple staff concern for the teeth on the lid as very rigid and sharp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8657827 |
| MDR Report Key | 8657827 |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-04-24 |
| Report Date | 2019-05-22 |
| Date Reported to FDA | 2019-05-22 |
| Date Reported to Mfgr | 2019-05-31 |
| Date Added to Maude | 2019-05-31 |
| 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? SANI-CLOTH BLEACH |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2019-05-31 |
| Model Number | 692965 |
| Catalog Number | 692965 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-05-31 |