MAUDE Adverse Event Report: UNOMEDICAL UK UNO OR/SECUREMENT; ACCESSORIES, CATHETER

Model Number	037449
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: sex: female.(b)(6).Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 1000317571.
Event or Problem Description
It was reported "emergency c section morning of (b)(6) 2023.Surgical dressing was removed on the second home visit from a midwife from the hospital, 3 days post delivery.Within 12 hours after the dressing had been removed rash appeared on my torso and back which had the appearance of blisters (torso area and inner thigh) and a red hive like rash over the upper half of my back and over both shoulders.The rash continued to spread up the neck and chest.Within 24 hours the rash pigmentation around my torso started to change to a purple colour, which progressively got darker.My skin felt like it was burning, and the skin was inflamed so much that it was raised, bubbly and extremely hot to the touch.I was readmitted to sandringham hospital after visiting a g.P whom informed me to attend emergency immediately.Several doctors consulted with me and decided that i remain under hospital care until they could identify what the situation was.I was in hospital for 5 days (b)(6) 2023-(b)(6) 2023 and unable to care for my new born.".

• Brand Name: UNO OR/SECUREMENT
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): UNOMEDICAL UK; convatec ltd gdc, first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): UNOMEDICAL UK; convatec ltd gdc, first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 17728122
• Report Number: 1000317571-2023-00200
• Device Sequence Number: 17614259
• Product Code: KGZ
• UDI-Device Identifier: 00768455200658
• UDI-Public: 00768455200658
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2023

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 Model Number: 037449
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown