MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD (FEMALE); SPEEDICATH CH12 FEMALE

Model Number	2851201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.Device has not been received.
Event or Problem Description
This case involves a female end user that had been using the speedicath catheter¿s for about 5 days when she experienced pain in her side.She went to hospital where she was diagnosed with covid and sepsis and was admitted to the hospital on (b)(6) 2020.She was informed by the physician in the covid unit that the sepsis was caused by catheterization and was treated with antibiotics.The end user claims she had some challenges using the catheters but disposed of the catheters correctly.The end user was moved to the rehab ward on (b)(6) 2020.Following her discharge tests were performed and she now believes the sepsis is healed.She was told she may need to take antibiotics for the rest of her life.The end user has follow-up appointments with her primary care physician and urologist scheduled.No additional information was provided.
Additional Manufacturer Narrative
A review of the lot number did not find any non-conformances or other complaints associated with the device.Testing of the returned samples confirmed all met specification.The issue could not be verified.

• Brand Name: SPEEDICATH STANDARD (FEMALE)
• Common Device Name: SPEEDICATH CH12 FEMALE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11229583
• Report Number: 3006606901-2021-00002
• Device Sequence Number: 3718325
• Product Code: GBM
• UDI-Device Identifier: 05708932020510
• UDI-Public: 05708932020510
• Combination Product (Y/N): N
• PMA/510(K) Number: K180258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/05/2021
• Device Model Number: 2851201400
• Device Catalogue Number: 28512
• Device Lot Number: 7175582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 12/30/2020
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 01/26/2021; 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 74 YR