MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NASOPORE FIRM 8CM, 8/PK; SPLINT, INTRANASAL SEPTAL

Catalog Number	5400020008
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Toxic Shock Syndrome (2108)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete; device used in patient.
Event or Problem Description
It was reported that after a surgical procedure involving nasopore product, the patient returned to the hospital with alleged toxic shock syndrome it was further reported that the patient required additional medical treatment to address the toxic shock symptoms it was also reported that the patient was treated successfully.
Additional Manufacturer Narrative
The product reported involved in this event was not returned for evaluation.The product was used during surgery on a patient.Without the product, the root cause cannot be determined.
Event or Problem Description
It was reported that after a surgical procedure involving nasopore product, the patient returned to the hospital with alleged toxic shock syndrome it was further reported that the patient required additional medical treatment to address the toxic shock symptoms it was also reported that the patient was treated successfully.

• Brand Name: NASOPORE FIRM 8CM, 8/PK
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7652324
• Report Number: 0001811755-2018-01109
• Device Sequence Number: 13865947
• Product Code: LYA
• UDI-Device Identifier: 37613154340805
• UDI-Public: 37613154340805
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5400020008
• Device Lot Number: 2017121213
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention