MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; REUSABLE INCO PANT,MEN,XXL,46-52"

Catalog Number BCPANTMENXXLZ

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Local Reaction (2035)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

It was reported by end user that he developed an allergic reaction (redness, and pain) related to use of medline product, reusable light incontinence pants.Per end user this was the first time he had received this item from his insurance company.The end-user stated that he had used the incontinence pants for two days (case/lot number unknown) when he started to develop slight redness and itching.End-user state's he continued to wear the product.End-user states that each day going forward the redness got worse and the soreness turned to pain after which he scheduled an appointment with a medical doctor (md).Md prescribed topical cream dermacerin and advised the end user to stop wearing the incontinence briefs.End user state's he applies the prescribed cream daily with relief.Reports, "after the third day there was great improvement however, continues to have some redness at the tip of his penis".End user reports he stopped wearing the incontinence pants the day the md advised him.End user denies having allergies.Reports incontinence issues are related to his diabetes and elevated sugar levels.Due to the reported reaction, and medical intervention this medwatch is being filed.Samples have not been returned for evaluation.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported by end user that he developed an allergic reaction (redness, and pain) related to use of reusable light incontinence pants.

Manufacturer Narrative

Changed/additional information added.G6 type of report: follow-up.H3 device evaluated by manufacturer: yes, evaluation summary attached.D9 device available for evaluation by the manufacturer: yes.Date returned to the manufacturer: 9/9/2020.H10 investigation report reads as follows: (b)(6) 2020, per evaluation of the sample sent in the qa engineer has informed me that he has been unable to find any quality issues with the reusable underwear.We have reviewed our trending reports and can confirm that this is an isolated issue that we will monitor closely with our trending reports.

Event Description

It was reported by end user that he developed an allergic reaction (redness, and pain) related to use of reusable light incontinence pants.

• Type of Device: REUSABLE INCO PANT,MEN,XXL,46-52"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10296642
• MDR Text Key: 204240490
• Report Number: 1417592-2020-00078
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: BCPANTMENXXLZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 134