MAUDE Adverse Event Report: ETHICON INC PROCEED VENTRAL PATCH; MESH, SURGICAL, POLYMERIC

Catalog Number PVPM1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: did the device come in contact with the patient? when did the device "crumble" was it when the staff removed product from sterile package or was it when the dr went to insert the device into the patient's cavity? (b)(6) 2017, during surgical procedure of herniorraphy, when opening the package of mesh, was found inappropriate for use because it falls apart when handling.The following information was requested but unavailable: was the seal of the sterile package intact? when sterile package was opened did the circulating nurse notice any holes in the sterile package? how was the product stored, was anything put on top of the device, temperature of room were product is stored?.

Event Description

It was reported that the patient underwent herniorraphy procedure on (b)(6) 2017 and mesh was used.During the procedure, when opening the package of mesh, it was found inappropriate for use because it falls apart when handling.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: (b)(4) 2018.An empty opened foil, an opened folder and a ventral patch of product code: pvpm, lot #: kd8cmcb0, were returned for analysis.During the visual inspection of the opened foil, showed excessive manipulation and multiples holes on the wrinkles consistent with excessive manipulation.The seal area was examined visually and it was noted to be complete and no damaged or wrinkles were present.Also, in the visual inspection of the mesh ventral patch body fluids and some degradation on support ring were observed as some of the components are absorbable.Per the foil condition the assignable cause was a result of pinholes in the foil consistent with excessive manipulation resulting in a degradation of the mesh ventral patch.

• Brand Name: PROCEED VENTRAL PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON GMBH; p.o. box 1409 d22841; norderstedt
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7178197
• MDR Text Key: 96846208
• Report Number: 2210968-2018-70168
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: PVPM1
• Device Lot Number: KD8CMCB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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