MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 KUGEL PATCH; SURGICAL MESH

Catalog Number	0010105
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a foreign object (dead insect) was found inside an unopened kugel patch product box.The subject device is said to be available however, at this time has not been returned.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 212 units.When/if the sample is returned a supplemental mdr will be submitted to document the evaluation results.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, during inspection, a foreign object (dead insect) was found inside an unopened kugel patch product box and unopened film.It was reported that there was no damage noticed on the outer/inner shell package.There was no patient involvement.
Event or Problem Description
As reported, during inspection, a foreign object (dead insect) was found inside an unopened kugel patch product box and unopened film.It was reported that there was no damage noticed on the outer/inner shell package.There was no patient involvement.
Additional Manufacturer Narrative
As reported, a foreign object (dead insect) was found inside an unopened kugel patch product box.The subject device is said to be available however, at this time has not been returned.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 212 units.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Evaluation of photos provided confirmed a foreign material (orange/brown in color) that appeared to be within the clear plastic wrap on the product carton.The evaluation of the returned sample found no foreign material on or within the packaging.The foreign material noted in the photos provided may have been on the outside of the film and fell off during the sample return process.The device inside of the product carton is in a sealed sterile pouch and was not compromised.Based on sample evaluation performed, no conclusion can be made.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: KUGEL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 22563631
• Report Number: 1213643-2025-00669
• Device Sequence Number: 9247585
• Product Code: FTL
• UDI-Device Identifier: 00801741016370
• UDI-Public: (01)00801741016370(17)290728(10)HUJU2004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0010105
• Device Lot Number: HUJU2004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown