MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL LLC RLSND131-2.5; SUBDERMAL NEEDLE

Model Number	RLSND131-2.5
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Medical device distributor reports that a foreign object was removed from a patient 3 days after surgery.The report was submitted to rhythmlink quality by rhythmlink's distributor pacific neurophysiological systems, through rhythmlink sales department by email and received on 24-jul-2019.The hospital was reported to be children's hospital at oakland\ucsf.The report contained only a photo of the foreign object.No other information was sent.Rhythmlink quality was unable to determine from the photo and lack of any other information, that the object was a piece of a needle, or that the object was from a piece of rhythmlink product.

• Brand Name: RLSND131-2.5
• Common Device Name: SUBDERMAL NEEDLE
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL LLC; 1140 1st street south; columbia SC 29209
• MDR Report Key: 8961064
• Report Number: 1067162-2019-00001
• Device Sequence Number: 2687948
• Product Code: GXZ
• UDI-Device Identifier: 10816312020202
• UDI-Public: (01)10816312020202
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/22/2020
• Device Model Number: RLSND131-2.5
• Device Catalogue Number: RLSND131-2.5
• Device Lot Number: P000010966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention