MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2011-02-22 for INTEGUSEAL* MICROBIAL SEALANT IS100 (NON-STERILE) 33734 manufactured by Kimberly-clark Health Care.
[1967502]
Kimberly-clark (b)(4), contacted the customer to verify that the non sterile integuseal they ordered and purchased was being placed in convenience kits and sterilized; however, the contact indicated they were not aware that the product they purchased was non sterile and were not sterilizing the product. User facility had potentially been using the non sterile integuseal in the operating room. They later contacted kimberly-clark to report that patients experienced infections following surgeries but did not have additional information regarding use of integuseal. Kimberly-clark has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9097239]
We were unable to review the device history record as no lot number was provided. Product code 33734 is a non sterile code that was developed for sale to end use customers/distributors or custom tray manufacturers to be packaged in kits that are then eo sterilized. The labeling states "not eo sterilized. Acceptable for use in products that may be eo sterilized. Caution: for manufacturing, processing, or repacking. " a notification has been sent to the customers who purchased non sterile integuseal to reinforce that the product is non sterile as the labeling indicates and requires sterilization by ethylene oxide prior to use. Information from this incident will be included in our product complaint and mdr trend reporting systems. Ongoing analysis of trend information is used to identify the need for additional investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617175-2011-00001 |
| MDR Report Key | 1997948 |
| Report Source | * |
| Date Received | 2011-02-22 |
| Date Added to Maude | 2011-02-22 |
| 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 | 0 |
| Manufacturer Contact | MR RA/QA AE COORDINATOR |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD BLDG 200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877200 |
| Manufacturer G1 | MEDLOGIC GLOBAL LTD |
| Manufacturer Street | WESTERN WOOD WAY LANGAGE SCIENCE PARK |
| Manufacturer City | PLYMOUTH, DEVON |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGUSEAL* MICROBIAL SEALANT IS100 (NON-STERILE) |
| Generic Name | INTEGUSEAL |
| Product Code | NZP |
| Date Received | 2011-02-22 |
| Catalog Number | 33734 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK HEALTH CARE |
| Manufacturer Address | 1400 HOLCOMB BRIDGE RD BLDG 200 ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-22 |