MAUDE Adverse Event Report: HOLOGIC, INC. ADIANA PERMANENT CONTRACEPTION SYSTEM; CONTRACEPTIVE DEVICE

Model Number A1000

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

Patient Problems Hair Loss (1877); Pain (1994); Rash (2033); Sleep Dysfunction (2517); Abdominal Cramps (2543)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review and sterile lot review were unable to be conducted for the disposable device as the lot number was not provided by the complainant.Internal complaint reference: (b)(4).

Event Description

It was reported by a patient that she had an adiana procedure nine years ago and has since suffered with her health including "random rashes on my body, extreme mood swings, extreme stomach cramps, muscle and joint pain, hair loss, back pain, stabbing pains in my pelvic, hot flushes, bowel issues and insomnia." "i've had various checks and tests and i know that one of the inserts is not intact properly and was leaking." "the (b)(6) will not reverse the procedure with removing everything which i do not want.".

• Brand Name: ADIANA PERMANENT CONTRACEPTION SYSTEM
• Type of Device: CONTRACEPTIVE DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8343313
• MDR Text Key: 136261675
• Report Number: 1222780-2019-00031
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2019

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 Model Number: A1000
• Device Catalogue Number: A1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/15/2019
• 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