MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO STANDARD INTERMITTENT CATHETER CH/FR 10 20CM

Catalog Number	72102
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	10/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of complaints for this product family over the last 3 years show no other reports citing no touch sleeve breaking off.The lot number is not known so device history records could not be reviewed.Neither the catheter nor the retrieved piece of the no touch sleeve were saved so sample review could not be conducted.Hollister cannot confirm that a piece of the vapro's no touch sleeve broke off.
Event or Problem Description
It was reported that an end user had been complaining about abdominal pain for the past 6 months.She saw her gp who referred her back to urology consultant.The consultant performed a scan where they saw something inside the bladder which they though could be mucus debris or blood.They also provided intravenous antibiotic treatment.A little bit later, they inserted a camera and removed from her bladder a 3.8 cm long fragment which they reported to be the vapro hydrophilic catheter's no touch sleeve.She had been experiencing bleeding and clots in her urine which immediately stopped following the removal of the fragment.The fragment that was removed was not saved; therefore hollister cannot independently confirm the fragment identification.

• Brand Name: VAPRO STANDARD INTERMITTENT CATHETER CH/FR 10 20CM
• Common Device Name: VAPRO STANDARD INTERMITTENT CATHETER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 12860296
• Report Number: 9616668-2021-00010
• Device Sequence Number: 11785626
• Product Code: GBM
• UDI-Device Identifier: 00610075065394
• UDI-Public: 00610075065394
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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 Catalogue Number: 72102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 57 KG