MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A0C01, STEALTH INSERT SZ 1 L/L 10/BX; DXC

Model Number	3
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering confirmed the complainant's experience of a hole in the pouch.The root cause of the event is likely due to shipping and handling.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary to ensure the performance and safety of its products.
Event or Problem Description
Procedure performed: na.Incident description: "we finished our receiving inspection for invoice #93902737.Some of the products did not pass the receiving inspection because of particulate matter and so on.Please find the attached rejected report for the detailed information.We would like applied medical to issue credit memo for the rejected items, but we don't need credit memo only for g6000 (lot#1274065)." type of intervention: na.Patient status: na.

• Brand Name: A0C01, STEALTH INSERT SZ 1 L/L 10/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6637356
• Report Number: 2027111-2017-01836
• Device Sequence Number: 613346
• Product Code: DXC
• UDI-Device Identifier: 00607915113032
• UDI-Public: (01)00607915113032(17)210704(30)01(10)1273649
• Combination Product (Y/N): N
• PMA/510(K) Number: 3
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

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: 07/04/2021
• Device Model Number: 3
• Device Catalogue Number: 3
• Device Lot Number: 1273649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2016
• Initial Report FDA Received Date: 06/13/2017
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1