MAUDE Adverse Event Report: UNKNOWN, UNK UNKNOWN

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Date of event not provided by the complainant.Product name unknown; product unspecified.Product common name unknown; product unspecified - product code pag / pai.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Product catalog number unknown, product unspecified.Surgeon name not provided by the complainant.Implant date not provided by the complainant.Concomitant products - unspecified neomedic device and unspecified ams device; implant date(s) not provided by the complainant.G5: 510(k) unknown; product unspecified.As requested by the fda, we have made note of the product code in section g8.The product code listed is not necessarily the product code assigned to the device 510(k), but rather the product code that seems the most appropriate based on the surgical procedure in which the product was implanted.Product manufacture date unknown; lot number unknown.Based on the information provided by the complainant, details regarding a specific correlation between a cook biotech incorporated manufactured product¿s performance and the alleged injury remain unknown.A root cause of the claim allegations is inconclusive due to the lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.A follow-up mdr will be filed if additional details are obtained.Date of event not provided by the complainant.

Event Description

The patient was reportedly implanted with an unspecified neomedic device and an unspecified ams device for treatment of stress urinary incontinence and pelvic organ prolapse.Specifics regarding date of implant, surgeon¿s name, and name of the facility where the implant occurred were not provided by the complainant.The patient reportedly underwent an extensive revision on (b)(6) 2013 to locate and remove mesh that was holding her bladder in the wrong position and causing extreme pain which remains ongoing.The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.Cook was named as a defendant in the litigation; however, the complainant did not specify that a cook device was implanted in the patient.

• Brand Name: UNKNOWN
• Manufacturer (Section D): UNKNOWN, UNK; unknown; unknown; unknown
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 6335187
• MDR Text Key: 67549691
• Report Number: 1835959-2017-00001
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/15/2017

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: Other
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 02/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PLEASE SEE ADDITIONAL INFO SECTION H10/11.
• Patient Outcome(s): Disability