MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PREC RT ANG RES UNTZ MH; PRECISION

Model Number 82-3284

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Complaint sample was not returned for evaluation (remains implanted); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

A facility reported the patient had an unknown allergy after a hakim valve placement.

• Brand Name: PREC RT ANG RES UNTZ MH
• Type of Device: PRECISION
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11510109
• MDR Text Key: 240588716
• Report Number: 3013886523-2021-00120
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704041696
• UDI-Public: (01)10886704041696(17)190531(10)CRHBFH
• Combination Product (y/n): N
• PMA/PMN Number: K944222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 82-3284
• Device Catalogue Number: 823284
• Device Lot Number: CRHBFH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Date Device Manufactured: 06/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1