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

Model Number 3

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2016

Event Type  malfunction  

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 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
• Type of Device: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497133904
• MDR Report Key: 6637356
• MDR Text Key: 77556292
• Report Number: 2027111-2017-01836
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607915113032
• UDI-Public: (01)00607915113032(17)210704(30)01(10)1273649
• Combination Product (y/n): N
• PMA/PMN Number: 3
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1