MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-09-23 for MICROSCOPE manufactured by Hologic Inc..
[55480842]
Device history record (dhr) review was conducted for the review scope. No relationship can be established between dhr and current complaint. Mfg date: 06/2006. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55480843]
It was reported by the cytotechnologist on 08/25/2016, during "full manual reviews" using the thinprep imaging system she has to "lean in the microscope". When she arrived home from work on (b)(46) 2016 she noticed a square shaped red patch of skin much like a heat rash or sunburn on the bridge of skin on the top most part of her stomach underneath her chest. The area was blistering over. The cytotechnologist did not seek medical attention. She applied ointment for a few days and on (b)(6) 2016 her "injury had completely healed".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00240 |
| MDR Report Key | 5973363 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-09-23 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-08-23 |
| Date Added to Maude | 2016-09-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH ME 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MICROSCOPE |
| Product Code | MNM |
| Date Received | 2016-09-23 |
| Returned To Mfg | 2016-09-08 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-09-23 |