MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRIMO SAN

Model Number MXAPP

Device Problems Device Difficult to Setup or Prepare (1487); Connection Problem (2900); Difficult to Open or Remove Packaging Material (2922)

Patient Problem Blood Loss (2597)

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.The device involved in the complaint will not be returned by the patient for evaluation.Once the investigation is complete, a follow up report will be filed.(b)(4).Product will not be returned.

Event Description

(b)(4)."yesterday morning, tuesday, i had surprising difficulty opening the first trimo-san tube.I tried a second tube which was equally difficult i finally was able to pierce the end of one of the tubes.I then used the tube and was able to cover the inflatoball and insert as usual.But, when i removed the inflatoball tuesday evening, i was shocked to see blood - a nickel' size amount of slightly dark, slightly thicker looking blood on the ball along with a couple of other lighter smears of blood.But i am still concerned that the surprising effort it took to pierce the end of the tube loosened or broke off a tiny piece of the metal' that covers the tube opening.".

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.The device involved in the complaint will not be returned by the patient for evaluation.Once the investigation is complete, a follow up report will be filed.(b)(4).Update 06/12/2017.Investigation: no sample returned.Analysis and findings: an evaluation of the complainant sample could not be conducted since it will not be returned.The trimosan tube is purchased from a supplier and is packaged at coopersurgical with the applicator to form part number mx5030.For this complaint, a lot number was not furnished.A review of two year complaint history shows no complaints for this issue.The trimosan tube has a safety seal at the dispensing point and the seal is broken by using the pointed interior of the cap.Coopersurgical has attempted to contact the complainant multiple times, however, there has been no response.Thus, further information is not available.Regarding the safety seal on the trimosan tube, there have been no drawing changes since 2012 and trimosan has an expiration date of only two years.Without the sample, it is not clear what may have caused the difficulty in breaking the seal.Also, since further information is not available, it is not clear what may have caused the nickel sized blood.Will continue to monitor for trending.Correction and/or corrective action: this complaint condition is a level 4 and does not pose any patient risk.Complaints of this nature will be addressed by the cip initiative at coopersurgical.No further action is needed at this time.However, this complaint will be reopened and re-evaluated should the samples be returned.All complaints in the cip program are trended and reviewed on a quarterly basis by management at coopersurgical to determine appropriate course of action.Product will not be returned.

Event Description

(b)(4)."yesterday morning, tuesday, i had surprising difficulty opening the first trimo-san tube.I tried a second tube which was equally difficult, i finally was able to pierce the end of one of the tubes.I then used the tube and was able to cover the inflatoball and insert as usual.But, when i removed the inflatoball tuesday evening, i was shocked to see blood - a nickel' size amount of slightly dark, slightly thicker looking blood on the ball along with a couple of other lighter smears of blood.But i am still concerned that the surprising effort it took to pierce the end of the tube loosened or broke off a tiny piece of the metal' that covers the tube opening.".

• Brand Name: TRIMO SAN
• Type of Device: TRIMO SAN
• 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: 6581175
• MDR Text Key: 75856331
• Report Number: 1216677-2017-00037
• Device Sequence Number: 1
• Product Code: HGD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: MXAPP
• Device Catalogue Number: MXAPP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other