MAUDE Adverse Event Report: COOPERSURGICAL, INC. AMS WILSON KIT

Model Number 72403867

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Tears (2516)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is complete, a follow up report will be filed.(b)(4).Product was disposed by end user.

Event Description

(b)(4)."dr (b)(6) at (b)(6) used the penile elevation strap for a penoscrotal ipp.During the use of the strap the skin was torn and had to be repaired surgically.".

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is complete, a follow up report will be filed.Reference e-complaint-(b)(4).***update 07/05/2017*** *investigation no sample returned.Inspect stock product.*analysis and findings: the reported event cannot be verified due to absence of 72403867 ams wilson kit lot number, or return product for investigation.However, if affected device is returned in the future and made available for root cause analysis, complaint may be reopened and addressed as needed.The complaint details mention that it was noticed the scroto support (p/n 720-285) was sticky compared to previous older parts.It is unconfirmed or unknown what sticky implies in terms of adhesion level, however, an inventory check of part both pre-sterilization and post sterilization was obtained to determine if parts were affected by eo sterilization, or time.Both samples did not exhibit any stickiness, nor are they any different from each other.The post-sterilization part was manufactured july 2011, while the pre-sterilization was manufactured july 2017.The units were manufactured 6 years apart, and did not have any apparent surface texture difference between them.It is unknown how the scrotol support p/n 720-285 was used or undergone other treatment prior to use and without part returned, a thorough investigation/root cause could not be performed.It is not clear how the issue occurred with the information present.*correction and/or corrective action: corrective action is not warranted as the device was not returned for root cause investigation.Complaint will be monitored for trending.*corrective action level 4: none.Reason: complaint will be monitored to determine if there is any new trend for this complaint condition.*was the complaint confirmed? no.Other text : product was disposed by end user.

Event Description

Reference e-complaint-(b)(4)."dr (b)(6) at (b)(6) medical center ((b)(6)) in (b)(6) used the penile elevation strap for a penoscrotal ipp.During the use of the strap the skin was torn and had to be repaired surgically.".

• Brand Name: AMS WILSON KIT
• Type of Device: AMS WILSON KIT
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6647333
• MDR Text Key: 77922571
• Report Number: 1216677-2017-00045
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 72403867
• Device Catalogue Number: 72403867
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention