MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number SURGICELUNK

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

Patient Problems Wound Dehiscence (1154); Pain (1994); Swelling/ Edema (4577)

Event Date 12/23/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).It was reported via a journal article: h6.Component code: g07002 - device not returned.This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.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.1.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number(s).2.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative patient consequences described in the article? 3.Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? 4.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.5.Can specific patient demographics: initials; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates of study drugs be provided? citation: j.Oral maxillofac.Surg.2023; 52: 860¿868 https://doi.Org/10.1016/j.Ijom.2022.11.016 event related to mw # 2210968-2023-08106, mw # 2210968-2023-08107.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.

Event Description

It was reported via a journal article: title: influence of a resorbable collagen membrane for alveolar bone graft on clinical outcomes and ridge volume stability in cleft alveolus authors: t.Singkhorn, p.Pripatnanont, t.Nuntanaranont, d.Supakanjanakanti, w.Ritthagol citation: int.J.Oral maxillofac.Surg.2023; 52: 860¿868.Https://doi.Org/10.1016/j.Ijom.2022.11.016 the objective of this study is to compare the clinical outcomes, graft quality, and graft quantity after alveolar bone grafting with and without a resorbable collagen membrane.A total of 22 patients aged between 8 and 21 years.12 females and 8 males.Two patients, one from each group, were lost to follow-up due to the covid-19 pandemic.Twenty patients (10 in each group) were followed up for at least 6 months postoperatively.There was no case of infection after the operation, but wound dehiscence was observed in two cases, one in each group.The mb/membrane group patients reported significantly less postoperative pain than the st/standard group patients.The mb group showed a tendency for less swelling than the st group.Surgicel (ethicon, somerville, nj, usa) was used for hemostasis.The pedicle was closed with 2¿0 vicryl sutures and the wound was closed layer by layer using deep dermal 4¿0 vicryl (ethicon, raritan, nj, usa), subcuticular 4¿0 monocryl (ethicon), and steri-strips (3 m, saint paul, mn, usa) reported complications included wound dehiscence (n=2), postoperative pain (n=?), facial swelling (n=?).In conclusion, the collagen membrane facilitated predictable clinical outcomes in bone maturation, bone volume preservation, and bone bridging in the alveolar bone graft.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• 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 PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17987058
• MDR Text Key: 326295762
• Report Number: 2210968-2023-08104
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2023

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: SURGICELUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/23/2023
• 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