MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-01 for UNKNOWN_INSTRUMENTS_PRODUCT UNK_INS manufactured by Stryker Instruments-kalamazoo.
[164606205]
It was reported that the pressure was fluctuating during a case where a stryker smartpump was used and a stryker disposable tourniquet cuff. The possible harm associated with this event is blood loss and if this type of malfunction were to reoccur during a bier block procedure, it could pose the risk of systemic exposure to local anesthetic. There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[188148884]
It was reported that the pressure was fluctuating during a case where a stryker smartpump was used and a stryker disposable tourniquet cuff. The possible harm associated with this event is blood loss and if this type of malfunction were to reoccur during a bier block procedure, it could pose the risk of systemic exposure to local anesthetic. There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2019-03599 |
| MDR Report Key | 9266083 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-01 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2019-10-16 |
| Date Added to Maude | 2019-11-01 |
| 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 | MR. ZACH BAKER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_INSTRUMENTS_PRODUCT |
| Generic Name | TOURNIQUET, PNEUMATIC |
| Product Code | KCY |
| Date Received | 2019-11-01 |
| Catalog Number | UNK_INS |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-11-01 |