MAUDE Adverse Event Report: PHS CUSTOM PACKAGING BASIC PACK; TRAY, SURGICAL

Catalog Number 747474

Device Problems Hole In Material (1293); Sticking (1597); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

Contents paper was glued to outside of back table cover.It tore when trying to remove it.Unable to use because of hole.

• Brand Name: BASIC PACK
• Type of Device: TRAY, SURGICAL
• Manufacturer (Section D): PHS CUSTOM PACKAGING; 41980 winchester road; temecula CA 92590
• MDR Report Key: 5317755
• MDR Text Key: 34091895
• Report Number: 5317755
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015,12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2017
• Device Catalogue Number: 747474
• Device Lot Number: 1175612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR