MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA N/A

Catalog Number MKG-MAYFIELDND

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that an unspecified mayfield device failed during use on a patient and caused a laceration.Additional information has been requested.

Manufacturer Narrative

A duplicate report was submitted for this complaint event under mfg report number 3004608878-2021-00338.Consequently, no investigation results will be submitted for this event, as all information was previously submitted under mfg report number 3004608878-2021-00338.

Event Description

N/a.

• Brand Name: N/A
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 11810027
• MDR Text Key: 250183277
• Report Number: 3004608878-2021-00335
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MKG-MAYFIELDND
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1