FDA Adverse Event Injury Summary report: N

MERSILENE POLYESTER FIBER MESH

MDR report key: 3941615 · Received July 17, 2014

Report

Report Number: 2210968-2014-09402
Event Type: Injury
Date Received: July 17, 2014
Report Date: October 21, 2016
Manufacturer: ETHICON INC.
Product Code: FTL
PMA / PMN Number: K851086
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative · 1

(B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT HYMENOTOMY, CYSTOURETHROSCOPY AND PLACEMENT OF OPEN SUPRAPUBIC CATHETER (2004) DUE TO SUI AND EQUIVOCAL BLADDER CONTRACTION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, RECURRENCE AND BLADDER REMOVAL. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL DUE TO SUI AND FAILURE OF FIRST MESH ON (B)(6) 2004. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
419598	MERSILENE POLYESTER FIBER MESH	MESH, SURGICAL	FTL	ETHICON INC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention