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U.S. Department of Health and Human Services

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

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HOLLISTER INCORPORATED NEW IMAGE CONVEX FLEXTEND 57MM 2-1/4' FLG 29MM 1-1/8' PS NEW IMAGE CONVEX FLEXTEND BARRIER Back to Search Results
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.
 
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Brand NameNEW IMAGE CONVEX FLEXTEND 57MM 2-1/4' FLG 29MM 1-1/8' PS
Type of DeviceNEW 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 Key10212787
MDR Text Key197158157
Report Number1119193-2020-00012
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number15905
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/30/2020 Patient Sequence Number: 1
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