MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE HERNIA PACK (HPSPD)568; GENERAL SURGERY TRAY (KIT)

Model Number	SBAHFHPSPE
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on supplier investigation, the device history record could not be reviewed as lot number was not provided.No sample was provided for evaluation.A historical review of product (b)(4) was completed from 03-01-2017 to 05-02-2019.This is the only reported issue describing irritation from the adhesive on the drape.After evaluation we can describe as follows: all operators are certified in their respective operations and the operators or the quality inspector did not identify this condition during their process and continuous inspection.The drape is made with qualified, tested, and approved materials and was made to meet with their specification requirements.Based on the limited information available at this time and no product sample provided, the root cause could not be determined.If a sample is provided at a later date, the investigation will be re-opened, and an addendum report will be provided.
Event or Problem Description
The customer reported that a patient developed a red rash and severe itching on the abdomen from the adhesive on the minor procedure drape (b)(4) from the hernia pack (b)(4).The procedure performed was a hernia repair.Dexamethasone cream was prescribed and an over the counter antihistamine.The patient is now doing well with only mild residual redness.

• Brand Name: HERNIA PACK (HPSPD)568
• 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: 8712870
• Report Number: 1423537-2019-00325
• Device Sequence Number: 16706053
• Product Code: LRO
• UDI-Device Identifier: 10887488731780
• UDI-Public: 10887488731780
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/19/2019

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: SBAHFHPSPE
• Device Catalogue Number: SBAHFHPSPE
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/19/2019
• 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
• Patient Age: 65 YR