N
Patient 1
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).
MAUDE MDR 5973363
- MDR report key
- 5973363
- Report number
- 1222780-2016-00240
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-08-23
- Date received
- 2016-09-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS SIDRA PIRACHA
- Address
- 250 CAMPUS DRIVE MARLBOROUGH ME 01752 US
- Phone
- 508-508-5082
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MICROSCOPE | HOLOGIC INC. | MNM | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-23 | 0 | 1. O |
Event Narratives#
D
Patient 1
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".