MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-27 for PRESERVCYT manufactured by Hologic Inc..
[20214839]
Work related injury due to repeated opening of vials as part of work related activity. Operator is undergoing physical therapy on the right wrist and thumb, no pre existing condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2011-00079 |
| MDR Report Key | 2086715 |
| Report Source | 06 |
| Date Received | 2011-04-27 |
| Date of Report | 2011-04-26 |
| Date of Event | 2011-03-21 |
| Date Mfgr Received | 2011-04-14 |
| Date Added to Maude | 2011-05-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTINA HURTON |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638916 |
| Manufacturer G1 | HOLOGIC |
| Manufacturer Street | 2 PERIMETER RD EAST |
| Manufacturer City | LONDONDERRY NH 03053 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03053 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESERVCYT |
| Generic Name | CYTOLOGICAL PRESERVATIVE |
| Product Code | LEA |
| Date Received | 2011-04-27 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC. |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-04-27 |