MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-14 for UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNK_ICO manufactured by Stryker Instruments-kalamazoo.
[77523135]
A follow up report will be filed once the quality investigation is complete. Device used, not available for return.
Patient Sequence No: 1, Text Type: N, H10
[77523136]
It was reported post operatively, it was noted that the nasopore product was inhaled into the lungs of the patient in recovery. It was also reported a bronchoscopy procedure was required to remove the nasopore product from the patients lungs. It was further reported that there was no delay reported and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[113783678]
The reported event, for product dislocation, was not confirmed as the nasopore standard product was not returned for evaluation. Without the nasopore product, the root cause cannot be determined. A device history review(dhr) review was not possible in this event as the lot number was reported as unknown. Attempts to get more information in relation to the reported event were unsuccessful.
Patient Sequence No: 1, Text Type: N, H10
[113783679]
It was reported post operatively, it was noted that the nasopore product was inhaled into the lungs of the patient in recovery. It was also reported a bronchoscopy procedure was required to remove the nasopore product from the patients lungs. It was further reported that there was no delay reported and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-01312 |
| MDR Report Key | 6639700 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-06-14 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-06-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. 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 | UNKNOWN_INSTRUMENTSTIRE_PRODUCT |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2017-06-14 |
| Catalog Number | UNK_ICO |
| 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 | 2017-06-14 |