MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-11 for INTEGUSEAL MICROBIAL SKIN SEALANT 200IN 4 33737 991033737 manufactured by Halyard Health.
[21794982]
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. The healthcare professionals at the facility changed their clinical practices. One of these changes was to eliminate the use of the microbial skin sealant product. They claim that since the change in practice, the number of infections has decreased. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[22293247]
(b)(4). The product involved in the report has not been returned. A review of the device history record is in-progress. Upon completion of the investigation; a follow-up report will be filed. 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 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[29338245]
No sample returned. The product involved in the report has not been returned. The device history record for the lot number involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. 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
| Report Number | 3011270181-2015-00001 |
| MDR Report Key | 4838976 |
| Report Source | 05 |
| Date Received | 2015-06-11 |
| Date of Report | 2015-06-25 |
| Date Mfgr Received | 2015-07-25 |
| Date Added to Maude | 2015-07-09 |
| 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 | 0 |
| Event Location | 0 |
| 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 | HALYARD HEALTH |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGUSEAL MICROBIAL SKIN SEALANT 200IN 4 |
| Generic Name | MICROBIAL SEALANT (INTEGUSEAL) |
| Product Code | NZP |
| Date Received | 2015-06-11 |
| Model Number | 33737 |
| Catalog Number | 991033737 |
| Lot Number | P00202365 |
| Device Expiration Date | 2015-09-30 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-06-11 |