MAUDE Adverse Event Report: COVIDIEN SCD COMFORT KNEE LENGTH MED; SLEEVE, LIMB, COMPRESSIBLE

Model Number	74022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported a dermatitis occurred on the patient using the sleeve after surgery.The patient got a red rash in the shape of human on both legs.The patient was prescribed 0.05% antebate ointment + vaseline, 25% hychee granules to treat the rash.
Additional Manufacturer Narrative
Additional information: a review of the device history record (dhr) could not be performed because the lot number is unknown.All dhrs are reviewed for accuracy prior to product release.The physical sample involved in the report was not returned for evaluation; however, one photo was provided.A review of the photos shows a transfer of the graphic on the calf muscles of the patient, thus confirming the patient got a red rash in the shape of a human on both legs.The ink used during the manufacturing process has been tested and approved for skin contact per a biocompatibility study.The vendor guarantees that the material is manufactured based on cardinal health specifications and conforms to all requirements and acceptance criteria.The raw material batches are received with a certificate of conformity (coc) certifying that all quality characteristics have been tested and achieved the defined requirements.A root cause that may cause skin irritation could not be determined.This event is not considered as manufacturing related and no trends or triggers have been found.A corrective and preventive action (capa) is not deemed necessary at this time.It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling, are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: SCD COMFORT KNEE LENGTH MED
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 11132087
• Report Number: 3009211636-2021-00731
• Device Sequence Number: 19868417
• Product Code: JOW
• UDI-Device Identifier: 10884521130869
• UDI-Public: 10884521130869
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: No Information
• Device Model Number: 74022
• Device Catalogue Number: 74022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2020
• Supplement Date Received by Manufacturer: 12/26/2020
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other