MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE** RH; REMOVABLE (SKIN)

Catalog Number PRW35

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported two days after a c-section, the patient who had a large number of their staples fall out prior to the first dressing change following surgery.The patient was still in the hospital at the time this occurred.There was no further intervention required.Customer does not believe it to be user error as the staff and surgeons have used the devices for some time.

Manufacturer Narrative

(b)(4).

• Type of Device: REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: janice hinsey ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133373009
• MDR Report Key: 3675260
• MDR Text Key: 17611626
• Report Number: 3005075853-2014-01570
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRW35
• Other Device ID Number: BATCH # UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2014
• 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