MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD APPOSE ULC; STAPLE, REMOVABLE (SKIN)

Model Number	8886803512
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, at the end of cesarean section, during a skin closure, there were issues with the skin staplers.The patient had post-operative pain and was referred to the emergency room for staple removal.It was noted that they had a hard time removing the staples.The staples were removed using a staple extractor with local anesthetic.

• Brand Name: APPOSE ULC
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19032897
• Report Number: 9612501-2024-00883
• Device Sequence Number: 15288424
• Product Code: GDT
• UDI-Device Identifier: 10884521104365
• UDI-Public: 10884521104365
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K900486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2024

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 Expiration Date: 11/30/2024
• Device Model Number: 8886803512
• Device Catalogue Number: 8886803512
• Device Lot Number: J9M0692LY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/03/2024
• Date Device Manufactured: 12/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female