MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 7.0X105MM CANN SC TI 16TD; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	71107105
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient developed a skin problem in the hospital after surgery.Patient has been prescribed anything from antibiotics to antihistamines.The last doctor suggested a skin test to which came in positive for gold sodium thiosulfate.Patient now needs to get further metal tests to determine to which other metal he might be allergic so that he can get treatment.Symptoms: huge red spots with itching all over the body and scalp.They seem to be getting worse.He has undergone a skin scrape test, has been diagnosed with (possible) things like scabies, skin psoriasis, eczema, seasonal allergies, atopic dermatitis, etc.Just grasping for straws.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation please review attached for investigation results.(b)(4).

• Brand Name: 7.0X105MM CANN SC TI 16TD
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7134512
• Report Number: 1020279-2017-01304
• Device Sequence Number: 16164501
• Product Code: KTT
• UDI-Device Identifier: 03596010291295
• UDI-Public: 03596010291295
• Combination Product (Y/N): N
• PMA/510(K) Number: K993289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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 Catalogue Number: 71107105
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 03/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other