MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MODIFIED KUGEL PATCH; SURGICAL MESH

Catalog Number 0115816

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The condition of the unit was noted during inspection, there was no patient involvement.The lot contained (b)(4) units and were 100% inspected and only the one single unit exhibited this condition.A photo has been received and shows a cosmetic issue and creasing on the mylar portion or the pouch.We are unable to identify the extent of the damage to the pouch by reviewing the photo.The sample is expected to be returned to davol for evaluation.When the sample is received, an evaluation will be conducted to determine the extent of the damage.Once the evaluation has been completed, a supplemental mdr will be submitted to document the results.

Event Description

The following was reported to davol: as reported damage was noted on the mylar side of a sterile package during inspection.The contact reports concern for a possible compromise to the sterile barrier.

• Brand Name: MODIFIED KUGEL PATCH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5787309
• MDR Text Key: 49383920
• Report Number: 1213643-2016-00317
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 0115816
• Device Lot Number: HUAP1423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2016
• 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