MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE LAPAROTOMY PACK (LAASA)195; GENERAL SURGERY TRAY (KIT)

Model Number	SBA59LAASA
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided for this particular product code with lot number 0630ah1 this product was manufactured on march 3rd, 2020.According to the device history record review no quality issues were reported.The devices are made with qualified, tested, and approved materials and the review found that the product met all specification requirements.A review of complaints for this product number indicated that this was the first incident reported for this issue reported issue in the last 12 months.Without a sample provided we are unable to determine a root cause.If further information is provided or a sample received at a later date a follow-up report will be submitted.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature for this catalog number.
Event or Problem Description
The adhesive from the drape, 8554na, used in the sba59laasa laparotomy pack caused an allergic reaction to the patient.The patient had an anaphylactic response and was hospitalized.The patient had a localized reaction as well where the drape was placed on the skin.No patient demographics were provided when requested.

• Brand Name: LAPAROTOMY PACK (LAASA)195
• 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: 11577660
• Report Number: 1423537-2021-00616
• Device Sequence Number: 4266386
• Product Code: LRO
• UDI-Device Identifier: 10888439069846
• UDI-Public: 10888439069846
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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 Expiration Date: 08/01/2024
• Device Model Number: SBA59LAASA
• Device Catalogue Number: SBA59LAASA
• Device Lot Number: 420568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/26/2021
• 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: Hospitalization; Other