MAUDE Adverse Event Report: COOPERSURGICAL INC. GELLHORN

Model Number NOT PROVIDED

Device Problem Material Erosion (1214)

Patient Problem Fistula (1862)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

"i wanted to give you a heads up on a new complaint"."at the (b)(6) hospital." they have had a patient admitted with a fistula, needing reconstructive surgery to the bladder as it eroded through." "as a result, they health board have been told not to use the gellhorn until this is resolved " (b)(4).

Manufacturer Narrative

Reference: (b)(4).*investigation: x-no sample returned.X-review dhr.X-inspect stock product.*analysis and findings: an evaluation of the complainant sample could not be conducted since it will not be returned.This product was manufactured and packaged at coopersurgical in february 2018.A review of the dhr did not show any abnormalities.A review of the two year complaint history shows one other complaint.Finished goods inventory for the reported lot number has been depleted.A sampling of finished goods inventory (263383, 263384, 263385) found product was the correct pessary and met outside diameter size requirements.There has not been any specification changes in the last 2 years.Based on the information provided, the reported complaint condition could not be confirmed.Should the sample be returned, the complaint will be re-opened and evaluated.*correction and/or corrective action: no corrective action is required at this time.Coopersurgical will continue to monitor this complaint condition for trends.*was the complaint confirmed? no.*preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

"i wanted to give you a heads up on a new complaint"."at the (b)(6) hospital." they have had a patient admitted with a fistula, needing reconstructive surgery to the bladder as it eroded through." "as a result, they health board have been told not to use the gellhorn until this is resolved " ref: (b)(4).

• Brand Name: GELLHORN
• Type of Device: GELLHORN
• Manufacturer (Section D): COOPERSURGICAL INC.; 95 corporate drive; trumbull 06611
• MDR Report Key: 8772913
• MDR Text Key: 150532822
• Report Number: 1216677-2019-00197
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• PMA/PMN Number: D044995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other