MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-01-30 for COTTON UMBILICAL TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[98574223]
(b)(4). Surgical procedure. Seizures occurred, foreign body reaction occurred. 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.
Patient Sequence No: 1, Text Type: N, H10
[98574224]
It was reported that a pediatric patient underwent an unspecified implantation procedure on unknown date and umbilical tape was used to fixate an implant at the site of a rib. Estimated amount of tap left implanted was 2 inches. Post operatively the patient began experiencing an increase in the frequency of seizures. Subsequent explorations revealed? Foreign body? At the site where the umbilical tape was used. The surgeon reported that the wound has healed, no wound issues and no inflammatory parameters in the lab results. Additional information will be requested.
Patient Sequence No: 1, Text Type: D, B5
[104522593]
Pc(b)(4). Date sent to the fda: (b)(6)2018. 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. Additional information was requested and the following was obtained: tape placed around a vertebral lamina to help anchor spinal rod. Approximately 4 cm of tape. Patients seizure activity, elevated esr/crp and pain found to be related to occult urinary tract infection. Patient is 9 year old girl with dravet syndrome and early onset scoliosis. Patient is doing well and no plans to remove the tape at this time. The following information was requested, but unavailable: what was the date of the initial procedure? Can you explain what is meant by? Explorations?? Was any medical intervention provided to the patient?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2018-70513 |
| MDR Report Key | 7227461 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-01-30 |
| Date of Report | 2018-02-09 |
| Date Mfgr Received | 2018-02-09 |
| Date Added to Maude | 2018-01-30 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COTTON UMBILICAL TAPE UNKNOWN PRODUCT |
| Generic Name | UMBILICAL CORD TAPE |
| Product Code | FOD |
| Date Received | 2018-01-30 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-30 |