MAUDE Adverse Event Report: SAGE IN-VITRO FERTILIZATION INC. PURECEPTION 80 PERCENT LOWER PHASE GRADIENT; PURECEPTION MEDIA

Catalog Number ART-2080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 07/15/2014

Event Type  Injury  

Event Description

"we have received complaint from the (b)(6) that in one of our sperm laboratory unit, three women where insemination (iui) from sperm donations and almost immediately after injection (after half an hour) developed intense pain in the lower abdomen and leukocytes from 14 to 18 thousand, the sperm donations were from different donors, there were no similar cases in the past, the injection was prepared by different employees and medical staff believes that due to the rapid development of symptoms it seemed to them that the cause is not a bacterial infection but rather a toxic response.".

Manufacturer Narrative

(b)(4).

• Brand Name: PURECEPTION 80 PERCENT LOWER PHASE GRADIENT
• Type of Device: PURECEPTION MEDIA
• Manufacturer (Section D): SAGE IN-VITRO FERTILIZATION INC.; pasadena CA
• Manufacturer Contact: nana banafo ; 75 corporate dr; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4058319
• MDR Text Key: 4865864
• Report Number: 2031459-2014-00003
• Device Sequence Number: 1
• Product Code: MQL
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2015
• Device Catalogue Number: ART-2080
• Device Lot Number: D197C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention