MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 ROCHESTER MEC WIDEBAND L 30BX

Catalog Number 36304

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that there was so much adhesive on the catheter that it removed the patient's skin.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that there was so much adhesive on the catheter that it removed the patient's skin.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that there was so much adhesive on the catheter that it removed the patient's skin.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that there was an excessive amount of adhesive on the catheter.As a result, the patient's skin was allegedly removed.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that there was an excessive amount of adhesive on the catheter.As a result, the patient's skin was allegedly removed.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that there was an excessive amount of adhesive on the catheter.As a result, the patient's skin was allegedly removed.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that there was an excessive amount of adhesive on the catheter.As a result, the patient's skin was allegedly removed.

Manufacturer Narrative

Received 6 unopened lot samples.The complaint could not be confirmed.All of the catheters were within specification for adhesive peel strength.The samples were visually inspected and no obvious defects were noted.During the functional/performance evaluation; six samples were tested for adhesive peel strength.Six of the six samples were within specification for adhesive peel strength.The specification for a 6030 wide band catheter is 0.800 to 2.800 pounds.The catheters measured between 1.059 pounds and 1.662 pounds.The complaint could not be confirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: " gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.Do not use on irritated or compromised skin." (b)(4).

Event Description

It was reported that there was an excessive amount of adhesive on the catheter.As a result, the patient's skin was allegedly removed.

• Brand Name: ROCHESTER MEC WIDEBAND L 30BX
• Type of Device: MEC
• Manufacturer (Section D): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. MN 32690 ; MX 32690
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. MN 32690 ; MX 32690
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5781863
• MDR Text Key: 49143596
• Report Number: 1018233-2016-00870
• Device Sequence Number: 1
• Product Code: NNX
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 36304
• Device Lot Number: NGAQ2530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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