MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-06 for 1392 5.9MM STRYKER SHEATH 2 WAY -NS 281392 manufactured by Depuy Mitek Llc Us.
[110231523]
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4)? Incomplete. The expiration date is not currently available.
Patient Sequence No: 1, Text Type: N, H10
[110231524]
It was reported that scope sheath was continuously leaking. There was no patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-51386 |
| MDR Report Key | 7573543 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2018-06-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | DEPUY MITEK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1392 5.9MM STRYKER SHEATH 2 WAY -NS |
| Generic Name | RIGID ENDOSCOPE SHEATH |
| Product Code | HRX |
| Date Received | 2018-06-06 |
| Catalog Number | 281392 |
| Lot Number | 61918007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Brand Name | 1392 5.9MM STRYKER SHEATH 2 WAY -NS |
| Generic Name | RIGID ENDOSCOPE SHEATH |
| Product Code | HNX |
| Date Received | 2018-06-06 |
| Catalog Number | 281392 |
| Lot Number | 61918007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-06 |