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 DEVICE PS1240 manufactured by Zipline Medical.
[182698983]
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 additional information was available.
Patient Sequence No: 1, Text Type: N, H10
[182698984]
Following completion of a total knee arthroplasty, medical staff performed surface closure with a zip 24 surgical skin closure device. The facility reported that the incision began "draining consistently since day of surgery" and that the physician chose to re-admit the patient for irrigation and debridement and re-closure of the incision on pod 5.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009673389-2020-00002 |
| MDR Report Key | 9759477 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-26 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2019-11-18 |
| Device Manufacturer Date | 2019-09-30 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| 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 DEVICE |
| Generic Name | TAPE-BASED WOUND CLOSURE |
| Product Code | KGX |
| Date Received | 2020-02-26 |
| Model Number | PS1240 |
| Catalog Number | PS1240 |
| Lot Number | 0000135824 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |