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

Model Number 404031

Device Problems Nonstandard Device (1420); Material Puncture/Hole (1504); Material Too Rigid or Stiff (1544)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No lot number is available.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional patient/event details have been requested but none have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

The end user reported the pouch closure clip had a rough texture which caused a tear in the pouch and subsequently resulted in stool leakage into her panties.She further reported that she was treated with an unspecified oral antibiotic (¿possibly cipro¿) for a urinary tract infection which she believes was a result of the stool leakage.The clip was replaced.The end user stated ¿that the clips have not been smooth for some time¿ citing an unknown quantity, unknown number of affected lots and unknown market units.No further information or photograph was provided.

• Brand Name: NATURA
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 7850528
• MDR Text Key: 119352265
• Report Number: 9618003-2018-01225
• 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
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404031
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71