MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; SPLINT, INTRANASAL SEPTAL

Catalog Number UNK_ICO

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

The quality investigation is complete.Product discarded.

Event Description

The customer reported via the sales rep that that after performing nasal surgery, the customer used nasopore forte.It was also reported that the patient returned to hospital 3 days later with pain and was reportedly diagnosed with an infection in the nasal cavity.It was further reported that the patient was prescribed antibiotics.It was also reported that all the packaging was discarded and that the lot/serial number and the part number is unknown.The customer further reported that this nasopore forte was part of the same batch as used in a previous complaint, however this cannot be confirmed.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• Type of Device: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 5245351
• MDR Text Key: 31965915
• Report Number: 0001811755-2015-04256
• Device Sequence Number: 1
• Product Code: LYA
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K052099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ICO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other