MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2009-04-29 for SOFT CIRCUMCISION STRAP, INFANT 37500 manufactured by Kimberly Clark Corporation.
[1232558]
Kimberly-clark has received a complaint that indicating that the straps are coming apart at the velcro connection when no pressure has been applied. The user hospital has not reported any injuries related to this product problem. 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
[8409169]
Sample has not been received for evaluation. Without a lot number, the device history record cannot be reviewed. Investigation is in-process. Supplemental report will be sent when additional information becomes available. 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 | 9616096-2009-00003 |
| MDR Report Key | 1454765 |
| Report Source | 05,06,08 |
| Date Received | 2009-04-29 |
| Date of Report | 2009-04-29 |
| Date of Event | 2009-03-30 |
| Date Mfgr Received | 2009-03-30 |
| Date Added to Maude | 2010-07-28 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1400 HOLCOM BRIDGE RD, B200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877200 |
| Manufacturer G1 | KIMBERLY-CLARK CORP. |
| Manufacturer Street | KM 4.5 CARRETERRA PRESA LA AMISTAD |
| Manufacturer City | CIUDAD DE ACUNA, COAHUIL 26200 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 26200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT CIRCUMCISION STRAP, INFANT |
| Generic Name | CIRCUMCISION SET |
| Product Code | OHG |
| Date Received | 2009-04-29 |
| Catalog Number | 37500 |
| 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 26200 MX 26200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-29 |