MAUDE Adverse Event Report: MORCHER GMBH RING, ENDOCAPSULAR

Model Number CTR11R

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2023

Event Type  malfunction  

Event Description

Description, reported by the vendor to the manufacturer on 10-mar-2023: it was reported that ctr was removed because dr.(b)(6) said it was bent.Unknown on lot number of the product.Unknown product can come back.Patient contact.Emailed the reporter a few times to obtain additional information to no avail.Additional information was requested from the vendor by the manufacturer on 16-mar-2023.On 03/30/2023 the vendor stated that no further information will be provided by the account and the product will not be returned.Initial reporter of this event with the medical device fortifeye ctr, model ctr11r (pma: p010059 s006), was: (b)(6) no information (serial number or lot) of the used device was given by the facility.The product will not be returned to the manufacturer.No product related investigation (review of dhr and measurement protocols) could be conducted.A trend analysis was performed.The occurence of the product problem since 2014 is "unlikely".The trend analysis shows an indication for a decreasing trend.

• Brand Name: RING, ENDOCAPSULAR
• Type of Device: RING, ENDOCAPSULAR
• Manufacturer (Section D): MORCHER GMBH; stuttgart 70374 DE; GM 70374 DE
• MDR Report Key: 16707271
• MDR Text Key: 313065372
• Report Number: MW5116485
• Device Sequence Number: 1
• Product Code: MRJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTR11R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FORTIFEYE CTR11R