MAUDE Adverse Event Report: SC003 SC-FORT MILL SHOULDER PACK (SHWCZ)683; GENERAL SURGERY TRAY (KIT)

Model Number SOP12SH10A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Caustic/Chemical Burns (2549); No Code Available (3191)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

Based in the information provided for the product number (b)(4) with lots numbers 1379mr1 / 2249mr1, the first lot of this product was manufactured on may 17th, 2019, and second lot was manufactured on august 12th, 2019.Based in the information provided for the product number (b)(4) with lot number 1449lr2, this product was manufactured on may 24th, 2019, and according with the device history record reviewed no quality issues were reported.Current process was evaluated based on the following: manpower: the responsible operators are properly trained and certified in their task.Machine: all parameters were within the validated process windows.Calibration and maintenances programs are properly performed.Material: materials for assembling code (b)(4) met the current specification requirements.Process/method: instructions for assembling code (b)(4) were reviewed, all of them (specifications, standard production method and visual aid) were properly documented and posted.During pfmea (process failure mode effect analysis) #13 was also reviewed and no change was required.Inspection/measurement: two inspections method took place during the assembly process: in process and cusum (accumulative sum) inspection.Device history record and in process quality report documented during the production of the product (b)(4) were reviewed.There were no comments for skin irritation issue related.Environment: no environment factor had a potential cause in the defect reported.Root cause or most probable cause: assembly process was reviewed for code (b)(4) reported with skin irritation issue, current adhesive tape met the specification requirements; no deviation was confirmed at this time.Current process was evaluated based on the following: manpower: the responsible operators are properly trained and certified in their task.Machine: all parameters were within the validated process windows.Calibration and maintenances programs are properly performed.Material: materials for assembling code (b)(4) met the current specification requirements.Process/method: instructions for assembling code (b)(4) were reviewed, all of them (specifications, standard production method and visual aid) were properly documented and posted.During pfmea (process failure mode effect analysis) #13 was also reviewed and no change was required.Inspection/measurement: two inspections method took place during the assembly process: in process and cusum (accumulative sum) inspection.Device history record and in process quality report documented during the production of the product (b)(4) were reviewed.There were no comments for skin irritation issue related.Environment: no environment factor had a potential cause in the defect reported.Root cause or most probable cause: assembly process was reviewed for code (b)(4) reported with skin irritation issue, current adhesive tape met the specification requirements; no deviation was confirmed at this time.As no abnormalities were found, no actions will be taken at this time.We will continue to monitor these products for any trends.

Event Description

Based on information received by the operating room director, the patient allegedly suffered a severe burn/reaction which led to a skin graft.The hospital was unable to determine which drape may have allegedly caused the burn/reaction.

• Brand Name: SHOULDER PACK (SHWCZ)683
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• Manufacturer (Section G): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 9512291
• MDR Text Key: 172487684
• Report Number: 1423537-2019-00385
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439610109
• UDI-Public: 10888439610109
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SOP12SH10A
• Device Catalogue Number: SOP12SH10A
• Device Lot Number: 556087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Date Device Manufactured: 10/04/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 76