MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CONVEX FLEXTEND 57MM 2-1/4' FLG 29MM 1-1/8' PS; NEW IMAGE CONVEX FLEXTEND BARRIER

Catalog Number 15905

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Blood Loss (2597)

Event Date 06/13/2020

Event Type  Injury  

Manufacturer Narrative

End user's weight not known so estimation used.Trend data reviewed and no adverse trend observed.Dhr review could not be conducted because lot number is not known.Sample review not possible because no sample available.The root cause of the stoma bleed cannot be determined however the combination of using a barrier with an opening too small for his stoma size combined with the patient being on two blood thinners likely contributed to the stoma injury and resulting blood loss.

Event Description

It was reported that an end user experienced a stoma bleed after being placed in a barrier with a smaller stoma opening.He was advised by his stoma nurse that he needed to be in a smaller barrier, which he used but then experienced a bleeding stoma.He went to the emergency department where they used a gel dressing and gave him a blood transfusion.Later that day, the stoma started bleeding again so they used silver nitrate cautery.The bleeding has since subsided.Hollister is providing him barriers with a larger stoma opening.

• Brand Name: NEW IMAGE CONVEX FLEXTEND 57MM 2-1/4' FLG 29MM 1-1/8' PS
• Type of Device: NEW IMAGE CONVEX FLEXTEND BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville, il
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft, va
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., ; 6802170
• MDR Report Key: 10212787
• MDR Text Key: 197158157
• Report Number: 1119193-2020-00012
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/30/2020

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 15905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 82