MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN ANAL IRRIG SYSTEM; RECTAL CATHETER

Model Number	2912901400
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Skin Tears (2516)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.However, as no lot number is provided it is impossible to trace the relevant product documentation and check if similar faults were registered from the particular production lot or check ncr's.No additional complaints registered about this item no.Current month same issue.The complaints are monitored closely for a forming trend and reported to management on a monthly basis.
Event or Problem Description
According to the available information, daughter started using pai around friday (b)(6).By (b)(6) she went to her school nurse and reported rectal bleeding and pain.She did not inform her mom until (b)(6).Her mom took her immediately to the er and doctors found no signs of bowel perforation, they instructed mom to go home and double laxative intake.End user is still suffering from light bleeding and mom informed me that her daughter has had a history of hemorrhoids and perhaps the hemorrhoid issue is far more serious than they were aware of.They have appointments scheduled to visit specialist to double check the feedback from the er.Additional information received: gi specialist discovered that end user has had a fissure & hemorrhoids during her use of peristeen.Mom was not clear on the grade or degree of the hemorrhoids, they were instructed to stop use of peristeen while they treat her current symptoms.The specialist is considering banding the hemorrhoids.The end user is really hoping to continue use of peristeen, but the hcp's will see if that will be an option based on how well she recovers.

• Brand Name: PERISTEEN ANAL IRRIG SYSTEM
• Common Device Name: RECTAL CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6503009
• Report Number: 3006606901-2017-00011
• Device Sequence Number: 18834949
• Product Code: KNT
• UDI-Device Identifier: 05708932544528
• UDI-Public: 05708932544528
• Combination Product (Y/N): N
• PMA/510(K) Number: K103254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: 2912901400
• Device Catalogue Number: 2912901400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR