MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE MAXILLO FACIAL PACK 635; GENERAL SURGERY TRAY (KIT)

Model Number	SEN73FPTAA
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record could not be reviewed as the lot number was not provided.A sample was not provided for evaluation.Since the towel is made of cotton, some lint is inevitable.Our supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.The suction process has been added before the product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria has been stipulated to see the suction results.(=0.38g/pieces).In the folding process, our supplier uses one cloth pad under 100 pieces semi-finished products to avoid linting being stuck onto the products during product's transfer.Based on the investigation, there is no abnormal situation noted that may have happened in production and all linting test data were within the acceptable range.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no other action taken at this time, however, our supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer reported that during a maxillo-facial procedure, the blue, non-x-ray, cotton or towels pwtb04-stm from the maxillo facial pack/ sen73fptaa were shedding threads and fuzz onto the instruments, patient and the implant/bone cement.The towels were used to surround the patient¿s face and to cover the back table.The patient developed a post-op infection requiring a trip back to the or for irrigation and debridement and post-op antibiotics.No further details regarding the infection or procedure were provided.No patient demographics or event date were provided after multiple attempts were made to gather the information.

• Brand Name: MAXILLO FACIAL PACK 635
• 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: 9287718
• Report Number: 1423537-2019-00370
• Device Sequence Number: 2448216
• Product Code: LRO
• UDI-Device Identifier: 10887488952598
• UDI-Public: 10887488952598
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: SEN73FPTAA
• Device Catalogue Number: SEN73FPTAA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention