MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-26 for ZIPSEAL 24 SURGICAL SKIN CLOSURE KIT PS1243 manufactured by Zipline Medical.
[182699704]
Insufficient information has been provided to allow for investigation. No photographic images were provided to the zipline territory manager to assist in the investigation. Requests for additional information were delivered, but no response was received.
Patient Sequence No: 1, Text Type: N, H10
[182699705]
Following completion of a total knee arthroplasty, the surgeon performed surface closure with a zipseal 24 convenience kit, which consists of a zipline zip 24 surgical skin closure device and cardinal health liquiband octyl 0. 8ml skin adhesive. Per the zipline territory manager, the physician reported that the patient developed a blister under the zip device. The surgeon chose to re-admit the patient and perform irrigation and debridement of the blister.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009673389-2020-00001 |
| MDR Report Key | 9759446 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-26 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-09-24 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-02-26 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 6840748 |
| Manufacturer G1 | ZIPLINE MEDICAL |
| Manufacturer Street | 747 CAMDEN AVE. SUITE A |
| Manufacturer City | CAMPBELL, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIPSEAL 24 SURGICAL SKIN CLOSURE KIT |
| Generic Name | TAPE-BASED WOUND CLOSURE & SKIN ADHESIVE |
| Product Code | MCY |
| Date Received | 2020-02-26 |
| Model Number | PS1243 |
| Catalog Number | PS1243 |
| Lot Number | 1917801 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |