MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 7.0X95MM CANN SC TI 16THD; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 71107095

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Event 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.

Manufacturer Narrative

The associated complaint device was not returned for evaluation please review attached for investigation results.(b)(4).

• Brand Name: 7.0X95MM CANN SC TI 16THD
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poektter ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 7134964
• MDR Text Key: 95385661
• Report Number: 1020279-2017-01305
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 03596010291271
• UDI-Public: 03596010291271
• Combination Product (y/n): N
• PMA/PMN Number: K993289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 71107095
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other