MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE STRAIGHT

Catalog Number	733008-G
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 4582 - no clinical signs, symptoms or conditions- event related to incorrect label amount / no patient harm.Impact code: 2199 - no health consequences or impact - no apparent harm occurred in relation to the adverse event.Device problem code : 1318 - labelling, instructions for use or training problem- incorrect label amount supplied.Component code:g 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 4-year review of similar complaints gelweave v gelweave jan 21 -may 25 could not be performed as this is the first event if incorrect label amount received reported.No trend requiring action has been identified.4111 - communication interview: additional information 3331 - analysis of production records: retained manufacturing and quality records for this batch will be reviewed.4117 - device not returned: device remains implanted investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available as investigation is ongoing.
Event or Problem Description
Gel weave straight received by customer with labels missing from inside carton.(only one was in there rather than the normal x 4 stickers) graft was implanted with no issues, the one label present was used.Hospitals use the spare stickers provided on documentation as needed, but in this case, they only had one.
Additional Manufacturer Narrative
4110manufacturer narrative: clinical code: 4582 - no clinical signs, symptoms or conditions- event related to incorrect label amount / no patient harm.Impact code: 2199 - no health consequences or impact - no apparent harm occurred in relation to the adverse event.Device problem code: 1318 - labelling, instructions for use or training problem- incorrect label amount supplied.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 4-year review of similar complaints gelweave v gelweave jan 21 -may 25 could not be performed as this is the first event if incorrect label amount received reported.No trend requiring action has been identified.4111 - communication interview: additional information was requested regarding the label which was received by the complainant, however to date they have been unable to inform us exactly which label from the set they received.3331 - analysis of production records: retained manufacturing and quality records for this batch were reviewed which showed no issues with the label printing , pack and inspection of this product 4117 - device not returned: device remains implanted investigation findings: 213 - no device problem found - manufacturing records were reviewed for the batch id-26069173 which showed no issues with the label printing/ scanning , packing and inspection of this batch.Labels are printed in a set of four of which one is scanned to allow the batch to progress, this step was completed with no issues noted.The batch also passed inspection to pack drawing 504 which indicates the labels are present at the time of pack.Review of the gelita gelweave ifu swap out process (removing the standard gelita ifu and adding in a patient information leaflet , australia ifu and australian patient implant card) could not be performed as australia will no longer receive gelita product going forward.Investigation conclusion: 4315 - cause not established - as the complainant could not determine which label they were supplied and the manufacturing / pack and inspection records for this batch showed no issues, we were unable to determine a root cause for this event.
Event or Problem Description
Gelweave straight received by customer with labels missing from inside carton.( only one was in there rather than the normal x 4 stickers) graft was implanted with no issues, the one label present was used.Hospitals use the spare stickers provided on documentation as needed, but in this case, they only had one.This report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00055 to provide event closure information for tag0249.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 22094860
• Report Number: 9612515-2025-00055
• Device Sequence Number: 20559470
• Product Code: DSY
• UDI-Device Identifier: 05037881105130
• UDI-Public: 05037881105130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 733008-G
• Device Lot Number: 26069173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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