MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-08-05 for SOFT CIRCUMCISION STRAP, INFANT 37500 manufactured by Kimberly-clark Corporation.
[915738]
It has been reported to the manufacturer by a sales representative that the velcro patch that hoods the strap together pulls off the strap when the baby kicks or strains against it. There was no report of any patient injury. 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. This product incident is documented in the kimberly-clark complaint database and identified.
Patient Sequence No: 1, Text Type: D, B5
[7889475]
The incident device has not been received for investigation; however, the device history record was reviewed finding no anomalies to be documented. Further investigation of this product revealed the root cause of this failure mode to be related to the hook and loop seal. New functional tests have been implemented that require a minimum of 2 rows of sealant on each side of the hoop-and-loop and straps as well as applying pressure once the hook-and-loop have been connected to the strap. Information from this incident will be included in our product complaint & 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 | 9616096-2008-00003 |
| MDR Report Key | 1098723 |
| Report Source | 05,06 |
| Date Received | 2008-08-05 |
| Date of Report | 2008-07-31 |
| Date of Event | 2008-07-08 |
| Date Mfgr Received | 2008-07-08 |
| Device Manufacturer Date | 2007-07-17 |
| Date Added to Maude | 2009-04-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD B200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877200 |
| Manufacturer G1 | KIMBERLY-CLARK CORPORPORATION |
| Manufacturer Street | KM 4.5 CARRETERRA PRESA LA AMISTAD |
| Manufacturer City | CIUDAD DE ACUNA, COAHUIL |
| Manufacturer Country | MX |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT CIRCUMCISION STRAP, INFANT |
| Generic Name | CIRCUMCISION STRAP |
| Product Code | GAX |
| Date Received | 2008-08-05 |
| Catalog Number | 37500 |
| Lot Number | AM7198A74 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORPORATION |
| Manufacturer Address | CIUDAD DE ACUNA, COAHUIL MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-05 |