MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE PODIATRY PACK (PYPTA)269; GENERAL SURGERY TRAY (KIT)

Model Number	SOP54PYPTA
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record could not be performed since a work-order/lot number was not provided for the reported incident.The sample for this reported incident was not available for further evaluation and therefore the exact cause could not be determined.At this time, no additional action will be taken, but we will continue to monitor the trend for this type of incident.
Event or Problem Description
Customer reported, ¿we are currently tracking infection from a case that occurred on (b)(6) 2019 and quality issue related to the manufacture of certain aami level 3 surgical gown.¿ customer has reported the procedure was a left foot bunionectomy, osteotomy of second and third metatarsals, second and third and fourth arthroplasty pij left foot, and plantar plate repair.The medical treatment provided for the infection was urgent care visit, hospitalization, oral and iv antibiotic therapy, return to surgery for i&d, removal of implants.Insertion of picc line by home health care.The prescriptive medication for the patient is po (oral) augmentin, iv antibiotics as well but the exact antibiotic given was not noted on the physician office record.As of (b)(6) 2020, patient was receiving home health care and iv antibiotics via picc line.

• Brand Name: PODIATRY PACK (PYPTA)269
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 9708632
• Report Number: 1423537-2020-00414
• Device Sequence Number: 11545448
• Product Code: LRO
• UDI-Device Identifier: 10887488375717
• UDI-Public: 10887488375717
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: SOP54PYPTA
• Device Catalogue Number: SOP54PYPTA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 93