MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL

Device Problem Migration (4003)

Patient Problems Erosion (1750); Nerve Damage (1979); Pain (1994); Discomfort (2330); Unspecified Tissue Injury (4559)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). No additional information is available. 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.  .

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2021 and the mesh was implanted. It was reported that the mesh arms were visible from poor placement. It was also reported that there was interference with bladder and bowel and affected the pudendal nerve. It was also reported that it prevented intimacy due to pain. The patient had a general unwell feeling and took over the counter codeine and mersyndol until it was given only on doctors scripts. It was reported that the patient's next step was morphine¿ patches which had little benefit. It was reported that the patient was now on tapendol everyday with often adding quick release while pain is at its peak. The patient's surgeon commented on the patient's mental capacity. No further information is available.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11868369
• MDR Text Key: 265975216
• Report Number: 2210968-2021-04881
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/23/2021
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/22/2021 Patient Sequence Number: 1