MAUDE Adverse Event Report: GEO-MED; MINOR ABDOMINAL TRAY

Model Number 89-6137.02

Device Problem Occlusion Within Device (1423)

Patient Problem Hyperglycemia (1905)

Event Date 07/30/2015

Event Type  malfunction  

Event Description

Upon opening a package for a minor abdominal tray distributed by geo-med, llc, (b)(4), lot 39072706, expiration date 06/202018, staff noted that a sterile towel had several dark colored spots that were approx 1 mm in size clearly visible on the towel.This is a custom package made for (b)(6).The pack was replaced and no harm to the pt or delay in pt care was experienced.

• Type of Device: MINOR ABDOMINAL TRAY
• Manufacturer (Section D): GEO-MED; altamonte springs FL 32701
• MDR Report Key: 4994477
• MDR Text Key: 22947725
• Report Number: MW5055296
• Device Sequence Number: 1
• Product Code: LRP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 89-6137.02
• Device Catalogue Number: 89-6137.02
• Device Lot Number: 39072706
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 1 DA