|
Catalog Number 1620002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Hernia (2240)
|
Event Date 05/05/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
|
|
Event Description
|
It was reported through a legal event that a 58 year old female patient had hernia repair surgery on or about (b)(6) 2015.During the hernia repair surgery the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2016 for a mesh removal operation.
|
|
Manufacturer Narrative
|
This is follow up #1 to report on december 6th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is (b)(6).No other information was reported.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
|
|
Event Description
|
This is follow up #1 to report on december 6th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is (b)(4).No other information was reported.As reported in the initial: it was reported through a legal event that a 58 year old female patient had hernia repair surgery on or about (b)(6) 2015.During the hernia repair surgery the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2016 for a mesh removal operation.
|
|
Manufacturer Narrative
|
Internal investigation into strattice lot sp100175 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 05/dec/2022 of the (b)(4) devices released to finished goods for lot sp100175, (b)(4) have been distributed with (b)(4) reported as implanted.Based on our internal investigation with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.As reported in follow up#1: this is follow up #1 to report on december 6th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100220-093.No other information was reported.The internal investigation is pending and will be reported in a follow up report along with the investigation conclusion.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
|
|
Event Description
|
This is follow up# 2 to report a correction to the lot, the results from the internal investigation and the conclusion.The aware date of january 5th 2023 is based on when the batch record review was completed.It was reported in follow up#1 that the lot associated with this event is sp100220-093; however, the correct lot is sp100175-038.As reported in follow up#1: this is follow up #1 to report on december 6th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100220-093.No other information was reported.As reported in the initial: it was reported through a legal event that a 58 year old female patient had hernia repair surgery on or about (b)(6) 2015.During the hernia repair surgery the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2016 for a mesh removal operation.
|
|
Search Alerts/Recalls
|
|
|