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Catalog Number 2020002 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hernia (2240); Post Operative Wound Infection (2446)
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Event Date 12/19/2013 |
Event Type
Injury
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Manufacturer Narrative
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Invalid product information.If additional information is received a follow up will be submitted.
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Event Description
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Follow up with legal on (b)(6) 2021.No updated information received strattice was confirmed usage.Reporting in an abundance of caution.On (b)(6) 2021 abbvie legal received a complaint from a legal patient representative.Documentation was submitted for two pieces of strattice used on a patient within 1 year of each other for a hernia repair.The product did not have valid lot numbers and limited information on the failure.We reported in an abundance of caution for the most current case under, 1000306051-2021-00043, but because it could not be confirmed why strattice failed in the first procedure and used again 1 years later.This mdr is for the first use of strattice in 2013.Allergan usa, inc., allergan, inc.And lifecell were served with these new strattice complaints on (b)(6) 2021.
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Manufacturer Narrative
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Review of the processing history records for lot s11222 is as follows: pouch integrity inspection showed no significant bulges, holes, tears, wrinkles or physical defects.The lot was aseptically processed, terminally sterilized, and met qc release criteria.There were no processing deviations or nonconformances related to the nature of this complaint.As of 07/11/22, of the 194 devices released to finished goods for lot s11222, 192 have been distributed, with 12 reported as implanted.
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Event Description
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Additional information was reported to abbvie on june 22, 20022 reporting the lot number associated with this complaint, lot s11222-65 was implanted on (b)(6) 2013.
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Search Alerts/Recalls
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