MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-16 for PRESERVCYT SOLUTION manufactured by Hologic, Inc.
[25900432]
A customer in (b)(6) reported that a nurse with an alcohol allergy touched a thinprep preservcyt solution vial without realizing it. The nurse washed with running water but started to receive tingling pain and went to the hospital. It was reported that the patient did not get an allergic reaction. This is a reportable event in the us since an allergic reaction to thinprep preservcyt solution could result in a potentially serious injury or illness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2015-00165 |
| MDR Report Key | 5080137 |
| Date Received | 2015-09-16 |
| Date of Report | 2015-09-15 |
| Date Mfgr Received | 2015-08-21 |
| Date Added to Maude | 2015-09-16 |
| 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 | EVA MAXWELL |
| Manufacturer Street | 2 NAVIGATOR ROAD |
| Manufacturer City | LONDONDERRY NH 03053 |
| Manufacturer Country | US |
| Manufacturer Postal | 03053 |
| Manufacturer Phone | 5082638922 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESERVCYT SOLUTION |
| Generic Name | PRESERVATIVE |
| Product Code | MKQ |
| Date Received | 2015-09-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-16 |