MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; MEIJER,PAD,XLARGE,SHEER,ADHESIVE,3"X4",1

Catalog Number MJ01726GV1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 08/27/2022

Event Type  Injury  

Event Description

According to the customer on (b)(6) she experienced an 'inflammatory reaction' after placing a bandage on her chest after bilateral piercings.Per the customer she stated she required urgent care and was prescribed 'fluocinonide cream and cephalexin,' to resolve the redness and burning.

Manufacturer Narrative

According to the customer on (b)(6) she experienced an 'inflammatory reaction' after placing a bandage on her chest after bilateral piercings.Per the customer she stated she required urgent care and was prescribed 'fluocinonide cream and cephalexin,' to resolve the redness and burning.Per the customer the area is healing and is reported to be doing better.No additional information is available at this time.The sample has been requested but has not been returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: MEIJER,PAD,XLARGE,SHEER,ADHESIVE,3"X4",1
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15456057
• MDR Text Key: 300245276
• Report Number: 1417592-2022-00172
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MJ01726GV1
• Device Lot Number: 220401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female