MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK3X10SW
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, some time post-operatively of a laparoscopic ventral hernia repair, during follow up due to discomfort, the surgeon discovered that a reload was in the patient¿s abdomen.The reload was removed from the patient in a separate procedure.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10252298
• Report Number: 1219930-2020-02730
• Device Sequence Number: 19502944
• Product Code: GDW
• UDI-Device Identifier: 10884521726376
• UDI-Public: 10884521726376
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RELTACK3X10SW
• Device Catalogue Number: RELTACK3X10SW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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: Other; Required Intervention