MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; PENROSE DRAIN, LATEX FREE, 18X0.5 STRL

Model Number MDT24A20

Device Problem Gas/Air Leak (2946)

Patient Problem Tissue Breakdown (2681)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported by (b)(6), end users spouse, which the end user, a quadriplegic recovering from bladder cancer has experienced more skin breakdown over the past several months reportedly due to air leaking from product mdt24a20, low air-loss therapy mattress.(b)(6) reports end user has a home health nurse that keeps track of end users skin breakdown.(b)(6) believes the skin breakdown is considered stage one and is treated with over-the-counter products, nutrition, and frequent position changes.There is no report of serious injury.The sample has not been returned and no evaluation completed.There is no further information at this time.There is no report of serious injury.However, due to the reported incident and in an abundance of caution this medwatch is filed.If additional relevant information becomes available, a supplemental med watch will be filed.

Event Description

It was reported the end user is experiencing more skin breakdown over the past several months due to the low air-loss alternating pressure mattress losing air.

Manufacturer Narrative

Changed/additional information added.D9 device available for evaluation -yes, date returned to manufacturer - 10/19/2020 g6 type of report: follow-up.H3 device evaluated by manufacturer - yes, evaluation summary attached.H6 type of investigation- 4101 and 4111.H10 investigation report reads as follows, 11/20/2020, "per the clinical investigation, visual inspection conducted with the samples that were provided.It was found from reviewing the two drains that they had torn near the end of the both drains.Per the packaging for the samples, it was stated that the account replicated the issue with some unused drains.Due to the clinical investigations, findings that the drains had torn inside the patient the reported concern will be confirmed.At this time a root cause cannot be determine.Our manufacturing site and the product manager will be notified of the issue.".

Event Description

It was reported, "when used in surgery to pull at either the stomach or bowel, the drain seems to fall apart/tear in the patient causing several patient safety concerns.".

• Brand Name: MEDLINE
• Type of Device: PENROSE DRAIN, LATEX FREE, 18X0.5 STRL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9959691
• MDR Text Key: 190774933
• Report Number: 1417592-2020-00035
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10080196549733
• UDI-Public: 10080196549733
• 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: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT24A20
• Device Catalogue Number: MDT24A20
• Device Lot Number: 02618090261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 54