IMPRESS/PK UNKNOWN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 1997-08-11 for IMPRESS/PK UNKNOWN * manufactured by Uromed Corp..

Event Text Entries

[19782687] Pt reported device migrated into her vagina. Device removed by medical professional.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1224675-1997-00043
• MDR Report Key: 112418
• Report Source: 04,07
• Date Received: 1997-08-11
• Date of Report: 1997-07-28
• Date of Event: 1997-07-23
• Date Mfgr Received: 1997-07-24
• Date Added to Maude: 1997-08-14
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IMPRESS/PK UNKNOWN
• Generic Name: IMPRESS SOFTPATCH
• Product Code: MNG
• Date Received: 1997-08-11
• Model Number: *
• Catalog Number: *
• Lot Number: UNK
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 110357
• Manufacturer: UROMED CORP.
• Manufacturer Address: 64 A ST. NEEDHAM MA 02194 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-08-11