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 2019-04-17 for ZIPSEAL 24 SURGICAL SKIN CLOSURE KIT PS1243 manufactured by Zipline Medical.
[142260009]
See user facility voluntary emdr report number mw5085079. On pod 1, patient suffered a traumatic fall, resulting in failure of deep sutures and subsequent partial dehiscence of surgical incision under the zip device. Based upon patient photographic image, there is no evidence of device malfunction.
Patient Sequence No: 1, Text Type: N, H10
[142260010]
Total knee arthroplasty patient was re-admitted to or for re-closure of surgical incision following a traumatic fall that resulted in failure of deep sutures and partial incision dehiscence. See voluntary report number mw5085079 generated by user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009673389-2019-00003 |
| MDR Report Key | 8524232 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-17 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2018-11-26 |
| Date Added to Maude | 2019-04-17 |
| 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 | MS. ARLEEN FELT |
| Manufacturer Street | 747 CAMDEN AVE. SUITE A |
| Manufacturer City | CAMPBELL CA 95008 |
| Manufacturer Country | US |
| Manufacturer Postal | 95008 |
| Manufacturer Phone | 4086840748 |
| Manufacturer G1 | ZIPLINE MEDICAL |
| Manufacturer Street | 747 CAMDEN AVE. SUITE A |
| Manufacturer City | CAMPBELL CA 95008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIPSEAL 24 SURGICAL SKIN CLOSURE KIT |
| Generic Name | WOUND DRESSING CONVENIENCE KIT |
| Product Code | MCY |
| Date Received | 2019-04-17 |
| Model Number | PS1243 |
| Catalog Number | PS1243 |
| Lot Number | 1901102 |
| Device Expiration Date | 2019-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIPLINE MEDICAL |
| Manufacturer Address | 747 CAMDEN AVE. SUITE A CAMPBELL CA 95008 US 95008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-17 |