MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-16 for E-Z DERM BIOSYNTHETIC WOUND DRESSING 131714-03 manufactured by Molnlycke.
[145619905]
An outer pouch seal failure was detected during pre-sterile product testing. The lab technician performing testing on the batch found the failure during immersion testing. The pouch was inflated and submerged in water in order to detect any leaks. Light pressure was applied to the pouch and the pouch seal failed entirely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004763499-2019-00004 |
| MDR Report Key | 8520961 |
| Report Source | OTHER |
| Date Received | 2019-04-16 |
| Date of Report | 2019-03-18 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2019-02-13 |
| Date Added to Maude | 2019-04-16 |
| 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 PAT STRAHL |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 4042700985 |
| Manufacturer G1 | RYNEL INC |
| Manufacturer Street | 11 TWIN RIVERS DRIVE |
| Manufacturer City | WISCASSET ME 04578 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 04578 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1225263-3/26/19-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-Z DERM BIOSYNTHETIC WOUND DRESSING |
| Generic Name | COLLAGEN WOUND DRESSING |
| Product Code | KGN |
| Date Received | 2019-04-16 |
| Returned To Mfg | 2019-02-26 |
| Model Number | 131714-03 |
| Lot Number | 19075976 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE |
| Manufacturer Address | 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-16 |