MAUDE Adverse Event Report: OMT LLC SPETZLER NEURO PATTIES; COTTONOID PATTIE

Model Number SPETZLER NEURO PATTIE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2015

Event Type  Injury  

Manufacturer Narrative

Although this complaint was discussed and evaluated with management team using the mdr decision tree, it was not reported because of the minimal data provided by the surgeon and or staff.Omt did not know if the surgeon had used our patties prior or if he had read the ifu.The definition of "serious injury" was applied to this complaint originally as we thought the patient had been harmed, however after the reporting party (hospital or) explained that the patient was not hurt and in fact was in good health condition, we felt we had no other recourse but to close the complaint.Thus, the mdr form was never filled out and the complaint (b)(4) and corrective action report (b)(4) were closed on 10/15/2015 without being reported to fda.

Event Description

U.S.Pediatric neurosurgeon, dr.(b)(6), left a message on our answering machine with a complaint on our product.We called back the same day and were advised the following: dr.(b)(6) explained that "during a tumor surgery he did recently, which took more time than usual" [he did not state how long was "usual" or the length of this surgery]." the patties stuck to the brain at the end of the surgery causing him to spend at least 3 more hours trying to remove the 5 patties that were stuck".He claimed that the patties dried out and stuck to the brain causing the brain to bleed when he was removing them, and even when irrigated, they did not come off easily.He further explained that "he had to go in and remove them very carefully because they were stuck to the "pia" which covers the brain and has a lot of blood vessels".We asked him to provide the product reference number and lot, but he did not know it.He promised to have his or people get that information to provide to us.He took our email address and promised to send details -- but never did.During our conversation dr.(b)(6) asked if the patties had a coating that made them stick? we explained that there was no coating on the patties.Dr.(b)(6) then asked what material they were made of? we explained that they were made of (b)(4).Dr.(b)(6) asked if we had had this issue before? we explained that we have never had any issues with our neuro patties adhering to the brain or any other area they have been used in since we first started selling them in 2005.We further invited him to check the fda website for reports of this nature.We told him that it was our understanding [per product instructions for use] that the patties should be irrigated with sterile physiological saline water before they are placed on the site and then are continuously irrigated to prevent sticking.We further asked him if the o.R team assisting him was doing this during the surgery; he avoided the response by saying that "it was a long surgery".We could not get him to confirm if or personnel had irrigated the patties during the surgery.After this conversation, we were never able to get any additional information from the surgeon, or staff or nurse.No one would return our calls or provide information requested.Although we were able to talk to his assistants, (b)(6), they were not able to [or would not] provide further details or information.The hospital continued to take our calls and messages but would not respond to our queries.Our subsequent attempts to obtain further information failed except for receiving confirmation from (b)(6) [one of dr.(b)(6)'s assistants] that the patient was in good health condition and that they were waiting for comments from the hospital administration to complete the form we sent to them (b)(4) "minimum complaint initial information form".However, the form was never returned to us although we continued to follow up and express our concern.We could only conclude from the minimal data provided, that patties were not irrigated as they should have been and; therefore, dried up and adhered to the tissue it was supposed to protect.

• Brand Name: SPETZLER NEURO PATTIES
• Type of Device: COTTONOID PATTIE
• Manufacturer (Section D): OMT LLC; 3848 sw 30th avenue; fort lauderdale FL 33312 6824
• Manufacturer Contact: luz escolar ; 3848 sw 30th avenue; fort lauderdale, FL 33312-6824 ; 9543275687
• MDR Report Key: 6362346
• MDR Text Key: 68529085
• Report Number: 3005663073-2017-00001
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/27/2017

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: Physician
• Device Expiration Date: 02/02/2020
• Device Model Number: SPETZLER NEURO PATTIE
• Device Catalogue Number: K-9020
• Device Lot Number: 4014250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/29/2015
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/29/2015
• Initial Date FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2015
• 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): Other
• Patient Age: 10 YR