MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-29 for NASOPORE FIRM 8CM, 8/PK 5400020008 manufactured by Stryker Instruments-kalamazoo.
[112799670]
A follow up report will be filed once the quality investigation is complete; device used in patient.
Patient Sequence No: 1, Text Type: N, H10
[112799671]
It was reported that after a surgical procedure involving nasopore product, the patient returned to the hospital with alleged toxic shock syndrome it was further reported that the patient required additional medical treatment to address the toxic shock symptoms it was also reported that the patient was treated successfully.
Patient Sequence No: 1, Text Type: D, B5
[117335523]
The product reported involved in this event was not returned for evaluation. The product was used during surgery on a patient. Without the product, the root cause cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[117335524]
It was reported that after a surgical procedure involving nasopore product, the patient returned to the hospital with alleged toxic shock syndrome it was further reported that the patient required additional medical treatment to address the toxic shock symptoms it was also reported that the patient was treated successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-01109 |
| MDR Report Key | 7652324 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-29 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-05-17 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-06-29 |
| 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 | MRS. UNA BARRY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASOPORE FIRM 8CM, 8/PK |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2018-06-29 |
| Catalog Number | 5400020008 |
| Lot Number | 2017121213 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-29 |