MAUDE Adverse Event Report: TELEFLEX UNKNOWN ARROW PAIN PUMP; PUMP, INFUSION, ELASTOMERIC

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

The friend or family member of the patient reported that the teleflex arrow pain pump was set at 2 but it did not seem to be alleviating the pain at all at their incision site.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN ARROW PAIN PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): TELEFLEX
• MDR Report Key: 17526683
• MDR Text Key: 321138143
• Report Number: MW5133621
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1