MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-08 for HAND SQUEEZE DEVICE manufactured by .
[5162422]
I was recently donating blood at the blood center in (b)(6), when i noticed the squeeze products used had blood droplets on them as if they were not sterilized or cleaned after each donor. This product was made of a sponge material in which blood probably saturates if not cleaned properly. I believe this product is very harmful from person to person.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038557 |
| MDR Report Key | 4174116 |
| Date Received | 2014-10-08 |
| Date of Report | 2014-10-08 |
| Date Added to Maude | 2014-10-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAND SQUEEZE DEVICE |
| Generic Name | HAND SQUEEZE DEVICE |
| Product Code | ION |
| Date Received | 2014-10-08 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-08 |