MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC

Model Number WOUND CARE-UNKNOWN SURGICAL COVER DRESSI

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

Dressing,wound,hydrophilic; nac.Based on the available information, this event is deemed to be a reportable malfunction.The complainant was only able to provide the product name.Complainant was unable to provide the model number, lot number or product sizing information.Per the information for use (ifu), the product should only be used for seven (7) days.Product used off-label or against the contraindications or not according to the ifu.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.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that an aquacel ag surgical dressing was difficult to remove on a patient that had total knee replacement.Due to the difficulty in removing the dressing, the patient experienced a skin tear.It was noted the dressing was in place for two weeks before removal.The complainant could not provide the product lot or material reference number to identify the exact dressing used.No photo or additional information was provided.

• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 7952881
• MDR Text Key: 123373012
• Report Number: 9618003-2018-02246
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WOUND CARE-UNKNOWN SURGICAL COVER DRESSI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1