MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC

Catalog Number SPMH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported by an attorney that the patient underwent a surgical procedure on (b)(6) 2015 and a mesh was implanted into the sub-muscular space to reinforce the diminished tissue. It was reported that the patient has experienced muscle loss, weight gain, continuous stomach pain especially when making any sort of contact with her stomach, loss of bowel function, increased diarrhea and stool related issues, and now must walk with a cane or a walk chair. No additional information was provided.

• Brand Name: PROLENE POLYPROPYLENE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6721233
• MDR Text Key: 106197814
• Report Number: 2210968-2017-32983
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2019
• Device Catalogue Number: SPMH
• Device Lot Number: JBB929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/18/2017 Patient Sequence Number: 1