MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-21 for INTEGUSEAL MICROBIAL SKIN SEALANT 200IN 4 33737 991033737 manufactured by Halyard Health.
[24778719]
(b)(4). The samples were received with the plunger fully depressed. There was no evidence of cyanoacrylate dispensing on the sponge applicator or on the exterior of the housing. The side welds were intact with no bulging. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24778720]
Halyard received a single report that referenced two different incidences, which were associated with separate units, involving two different reports. This is the second of two reports. Refer to 3011270181-2015-00016 for the first report. A report was received alleging that over the past year there have been an increase in the number of chest infections. No specifics on the infections were provided nor the number of occurrences. The timing of the increase corresponds with introduction on the microbial skin sealant product into operating room. It was reported that there have been times where the integuseal did not deploy any liquid. Exact date/number of occurrences was unknown. The devices were not retained for evaluation. The healthcare professionals at the facility changed their clinical practices. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2015-00017 |
| MDR Report Key | 5022743 |
| Date Received | 2015-08-21 |
| Date of Report | 2015-07-24 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-08-21 |
| 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. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
| Manufacturer Street | WESTERN WOOD WAY LANGAGE SCIENCE PARK |
| Manufacturer City | PLYMOUTH, DEVON PL75BG |
| Manufacturer Country | UK |
| Manufacturer Postal Code | PL75BG |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTEGUSEAL MICROBIAL SKIN SEALANT 200IN 4 |
| Generic Name | MICROBIAL SEALANT |
| Product Code | NZP |
| Date Received | 2015-08-21 |
| Returned To Mfg | 2015-06-22 |
| Model Number | 33737 |
| Catalog Number | 991033737 |
| Lot Number | P00202365 |
| Operator | NURSE |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-21 |