MAUDE Adverse Event Report: UNKNOWN PRODUCT-MED; TUBE, DRAINAGE, SUPRAPUBIC

Model Number UNKNOWN PRODUCT-MED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemostasis (1895)

Event Date 01/10/1980

Event Type  Injury  

Manufacturer Narrative

The complaint information has been forwarded to the supplier for investigation.Investigation results are pending at this time.A follow up report will be submitted once the investigation has been completed by the supplier.

Event Description

Customer had an out patient procedure and was sent home with 2 reservoir drains, product code unknown.Customer provided picture of 'like' product from the internet as the only product identification.Customer reports that both drains stopped working 2-3 days after placement and discharge from facility.Customer returned to doctor's office for manual drainage and subsequently doctor replaced drains with another product.No further consequences reported by customer.

Manufacturer Narrative

Based on the supplier¿s investigation, the device history record could not be reviewed as a lot number was not provided.The actual product code is unknown and a sample was not available for evaluation.Without the product code or the actual devices to evaluate, the root cause for the reported incident cannot be determined.No additional action will be taken at this time.If the product code or the devices become available for evaluation the complaint investigation will be reopened.

• Brand Name: UNKNOWN PRODUCT-MED
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• MDR Report Key: 8320968
• MDR Text Key: 135682095
• Report Number: 1423537-2019-00264
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN PRODUCT-MED
• Device Catalogue Number: UNKNOWN PRODUCT-MED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other