MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-01-22 for SURGICEL ABSORBABLE HEMOSTAT UNKNOWN manufactured by Ethicon Inc..
[185967161]
Product complaint # (b)(4). 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. Were the cases discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number. Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? Patient demographics. Citation: global spine journal. 2017; vol. 7(1s): 58s-63s. Doi: 10. 1177/2192568216688186. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185967162]
It was reported via a journal article: title: a multicenter study of the presentation, treatment, and outcomes of cervical dural tears authors: kevin r. O? Neill, md, ms; michael g. Fehlings, md, phd; thomas e. Mroz, md; zachary a. Smith, md; wellington k. Hsu, md; adam s. Kanter, md; michael p. Steinmetz, md; paul m. Arnold, md, facs; praveen v. Mummaneni, md; dean chou, md; ahmad nassr, md; sheeraz a. Qureshi, md, mba; samuel k. Cho, md; evan o. Baird, md; justin s. Smith, md, phd; christopher shaffrey, md; chadi a. Tannoury, md; tony tannoury, md; ziya l. Gokaslan, md, faans, facs; jeffrey l. Gum, md; robert a. Hart, md; robert e. Isaacs, md; rick c. Sasso, md; david b. Bumpass, md; mohamad bydon, md; mark corriveau, md; anthony f. De giacomo, md; adeeb derakhshan, bs; bruce c. Jobse, ba; daniel lubelski, md; sungho lee, md, phd; eric m. Massicotte, md, msc, frcsc; jonathan r. Pace, md; gabriel a. Smith, md; khoi d. Than, md; k. Daniel riew, md citation: global spine journal. 2017; vol. 7(1s): 58s-63s. Doi: 10. 1177/2192568216688186. The objectives of this retrospective multicenter case series study was to better understand the presentation, treatment, and outcomes following cervical dural tears. Multiple surgeons from 23 institutions retrospectively identified 21 rare complications that occurred between 2005 and 2011, including unintentional cervical dural tears. There were a total of 109 cases (age: 56. 9? 13. 8; 62 male and 47 female patients; bmi: 29. 0? 6. 7) of cervical dural tears reported. Intraoperative treatment of dural tear included sealant/patch materials such as surgicel (ethicon), evicel (ethicon), and surgifoam (ethicon). Reported complications included recurrent csf drainage (n-13) which required revision operative dural repair in 6 cases, delayed lumbar drain placement in 5 cases, and both revision surgery and lumbar drain placement in 2 cases, post-operative hematoma (n-2) which required revision operation, and infection (n-1) which required revision operation. This study is the largest reported series investigating cervical dural tears. In most cases no subsequent interventions to control csf drainage were required, while 12% required subsequent treatments. In a majority of cases, there was no clinical sequelae directly attributable to the occurrence of a dural tear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00590 |
| MDR Report Key | 9617745 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-01-22 |
| Date of Report | 2019-12-26 |
| Date Mfgr Received | 2019-12-26 |
| Date Added to Maude | 2020-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC. |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 088760151 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICEL ABSORBABLE HEMOSTAT UNKNOWN |
| Generic Name | AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED |
| Product Code | LMG |
| Date Received | 2020-01-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |