MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-08-02 for INPUT PS 8F 23CM INTRODUCER SHEATH 080023 manufactured by Medtronic Inc..
[666513]
It has been reported to us that the patient had an allergic reaction during the procedure. The physician inserted the introducer sheath into the patient. After some time, the patient had a severe allergic reaction immediately after the introducer was inserted. Attempts to obtain additional information including the exact product catalog and lot number involved in the case have been made.
Patient Sequence No: 1, Text Type: D, B5
[7907808]
Evaluation is anticipated upon receipt of the discrepant device. An engineering analysis of the subject device will be performed upon receipt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2007-00066 |
| MDR Report Key | 889213 |
| Report Source | 05,07 |
| Date Received | 2007-08-02 |
| Date of Report | 2007-07-24 |
| Report Date | 2007-07-24 |
| Date Mfgr Received | 2007-07-24 |
| Date Added to Maude | 2007-08-08 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | FRED BOUCHER, DIRECTOR |
| Manufacturer Street | 37A CHERRY HILL DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9787393116 |
| Manufacturer G1 | MEDTRONIC INC. |
| Manufacturer Street | 37A CHERRY HILL DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INPUT PS 8F 23CM INTRODUCER SHEATH |
| Product Code | DBY |
| Date Received | 2007-08-02 |
| Model Number | NA |
| Catalog Number | 080023 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 867808 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | 37A CHERRY HILL DR DANVERS MA 01923 US |
| Baseline Brand Name | INPUT PS 8F 23CM INTRODUCER SHEATH |
| Baseline Generic Name | INTRODUCER SHEATH |
| Baseline Model No | NA |
| Baseline Catalog No | 080023 |
| Baseline Device Family | INTRODUCER SHEATH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K901452 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-02 |