MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACTIVELIFE; POUCH, COLOSTOMY

Model Number 125358

Device Problems Material Too Rigid or Stiff (1544); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

The end user reported that approximately 2 weeks ago, she experienced bleeding and the blood "filled the bag".She then went to (b)(6) and had a 23 hours stay but was not admitted to emergency department.They applied pressure to the mucocutaneous junction and the bleeding subsided after approximately 10 minutes.Thereafter, she signed herself out.Later that day, the bleeding started again.She went to (b)(6) hospital in (b)(6).They drew blood and her "blood level" was 7.5 (presumably her hemoglobin) so they gave her 2 units of blood.She stated that her "blood level" was 8.7 when they sent her home the next day.She advised that her physicians were not sure why she had the bleeding as no visible injuries were detected to the stoma or peristomal skin but that the bleeding was coming from the mucocutaneous junction.Her stoma measures 32x45 mm and the stoma is flush to the skin at 9 o'clock.She further reported that she has a parastomal bulge that is "cantaloupe-sized".She had since stopped using this appliance.No photo is available at this time.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

H.6: device code corrected from 2993 to 1544.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: (b)(4).Manufacturing site: (b)(4).

• Brand Name: ACTIVELIFE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 9715407
• MDR Text Key: 179711616
• Report Number: 9618003-2020-00985
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125358
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1