MAUDE Adverse Event Report: ETHICON INC. SURGICEL POWDER CE - ABSORBABLE HEMOSTATIC PWDR; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 3023SP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Necrosis (1971); Tissue Damage (2104); Unspecified Tissue Injury (4559)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The initial information states full thickness disuse damage ¿ death.Please clarify ¿death¿ in this association.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? relevant patient history? any intraoperative concurrent use of other products? what was the condition of the patient¿s tissue prior to surgery? lot #? what was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? where was the surgicel used (on what tissue)? how much surgicel was used during the procedure? was the surgicel product left in place? was the excess irrigated and removed? what were current symptoms following the index surgical procedure? onset date? has any surgical or medical intervention been performed? what is physician¿s opinion as to the etiology of or contributing factors to this event? was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative tissue damage and death? what is the patient¿s current status?.

Event Description

It was reported that a patient underwent a facelift procedure on (b)(6) 2020 and absorbable hemostat was used.The surgeon used the absorbable hemostat for first time ever on a facelift case.The surgeon was told to sprinkle, less is more, and irrigate any excess.The surgeon inquired if the product can cause a burn, as there were signs of soft tissue damage.The patient suffered full tissue damage ¿ death.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch ppbaua mfg.Date - 12/4/2019, exp.Date - 5/31/2021." batch pmr587 mfg.Date - 11/12/2019, exp.Date - 4/30/2021.".

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 11/16/2020.Additional information: d4 - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: ppbaua or pmr587.Additional information was requested, and the following was obtained: i have not heard back from the surgeon as of yet ¿ it is likely he wont come back to me.See below.1.Date and name of index surgical procedure? face lift (rhytidectomy).2.The diagnosis and indication for the index surgical procedure? facelift.3.Any relevant patient history/comorbidities? unknown.4.Any intraoperative concurrent use of other products? no.5.Lot #? either ppbaua or pmr587.6.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? yes.7.Where was the surgicel used (on what tissue)? under the skin.8.How much surgicel was used during the procedure? half.9.Was the surgicel product left in place? was the excess irrigated and removed? excess was irrigated.The following information was requested, but unavailable: 1.What was the condition of the patient¿s tissue prior to surgery? 2.What were current symptoms following the index surgical procedure? onset date? 3.Has any surgical or medical intervention been performed? ? 4.What is physician¿s opinion as to the etiology of or contributing factors to this event? 5.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative tissue damage and death? 6.What is the patient¿s current status? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).H6.Component code: g07002 - device not returned.Additional information was requested, and the following was obtained: 1.Patient outcome & corrective action taken relevant to the care of the patient : patient outcome satisfactory through direct excision and healing by secondary intention.No further prescription offered.¿ this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SURGICEL POWDER CE - ABSORBABLE HEMOSTATIC PWDR
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9082183429
• MDR Report Key: 10642160
• MDR Text Key: 210216810
• Report Number: 2210968-2020-07668
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3023SP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/19/2020; 09/15/2020; 03/09/2022
• Supplement Dates FDA Received: 11/16/2020; 12/16/2020; 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 54 KG