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U.S. Department of Health and Human Services

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

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SC003 SC-FORT MILL SHOULDER PACK (SHWCZ)683 GENERAL SURGERY TRAY (KIT) Back to Search Results
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.

 
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Brand NameSHOULDER PACK (SHWCZ)683
Type of DeviceGENERAL 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 Key9512291
MDR Text Key172487684
Report Number1423537-2019-00385
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
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 Received12/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberSOP12SH10A
Device Catalogue NumberSOP12SH10A
Device LOT Number556087
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/04/2019
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/23/2019 Patient Sequence Number: 1
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