MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Scratched Material (3020)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: none provided in the article.(b)(4).

Event Description

Journal article title : unique development of tension-free vaginal mesh surgery for pelvic organ prolapse in japan m.The aim of this investigator initiated study was to describe the anatomical and functional outcomes of non-kit product based and trocar guided tension-free vaginal mesh (tvm) surgery for pelvic organ prolapse (pop).Between the periods of 2005 and 2010, 250 patients with pop were included in the study.Weak curved needle was inserted from skin located at 3 cm lateral and 3 cm dorsal point from anus and penetrate the sacrospinous ligaments about 2 cm medially from the ischial spines.#2 nylon strings are placed as a looped side at vaginal side.Gynemesh¿ was trimmed to fit in the size of individual vaginal length.The edge of the trimmed mesh was sutured to uterine cervix and perineal body with #0pds or proline.A gauze pack was left in the vagina for at least 24 to 48 hours.Severe mesh infection occurred in only one case and postoperative hematomas were observed in 3 cases.Mesh exposure occurred in 4 patients.Anatomical recurrences were observed in 8 patients and additional surgical treatments were necessary in 4 patients.In conclusion, japanese unique tvm repair with tailor-made trimmed mesh is well tolerated and anatomically and functionally highly effective and safe.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7725743
• MDR Text Key: 115218966
• Report Number: 2210968-2018-74663
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention