MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-11 for ZIPSTITCH LACERATION KIT PS2050 manufactured by Zipline Medical.
[141657256]
Device adhesion loss appears to have been caused by the patient's failure to fully control bleeding prior to device application.
Patient Sequence No: 1, Text Type: N, H10
[141657257]
Following an accidental arm laceration, the patient utilized the zipstitch laceration kit to clean and dry the wound and close it. Approximately 5 minutes after application, the wound began to bleed, causing adhesive failure of the zipstitch device. Patient reported to an urgent care center, where the wound was closed with sutures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009673389-2019-00002 |
| MDR Report Key | 8505415 |
| Report Source | OTHER |
| Date Received | 2019-04-11 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-03-10 |
| Date Mfgr Received | 2019-03-15 |
| Date Added to Maude | 2019-04-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | ZIPSTITCH LACERATION KIT |
| Generic Name | FIRST AID KIT WITHOUT DRUG |
| Product Code | OHO |
| Date Received | 2019-04-11 |
| Model Number | PS2050 |
| Catalog Number | PS2050 |
| Lot Number | 1834001 |
| Operator | LAY USER/PATIENT |
| 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 | 2019-04-11 |