MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH SIMPLEX HV WITH GENTAMICIN US 1 PACK; SIMPLEX HV GENTAMICIN

Catalog Number 6195-1-001

Device Problems Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned, retain sample will.

Event Description

Usimplex hv with gent was mixed and took much longer than normal to set up/harden.Doctor reported nearly 30 minutes for cement to set up.

• Brand Name: SIMPLEX HV WITH GENTAMICIN US 1 PACK
• Type of Device: SIMPLEX HV GENTAMICIN
• Manufacturer (Section D): AAP BIOMATERIALS GMBH; lagerstr.11-15; dieburg, 64807 ; GM 64807
• Manufacturer (Section G): AAP BIOMATERIALS GMBH; lagerstr.11-15; dieburg 64807 ; GM 64807
• Manufacturer Contact: lydia heimann ; lagerstr. 11-15; dieburg, 64807 ; GM 64807 ; 071929107
• MDR Report Key: 5337580
• MDR Text Key: 34751434
• Report Number: 9615014-2015-00008
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 6195-1-001
• Device Lot Number: 448BC963JV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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